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We aimed to evaluate a broad panel of in vivoinflammatory mediators in subjects with acute ORS symptomscompared to unaffected individuals following vaccination. Wealso aimed to evaluate hemagglutination inhibition HAI anti-body responses in subjects experiencing ORS compared to unaf-fected individuals following seasonal TIV vaccination, as titersmight differ between those with and without ORS.

This was a prospective observational study conducted dur-ing employee influenza immunization campaigns between October andDecember at two participating Canadian centers. The study wasapproved by the research ethics board of each center, and each participantprovided informed consent. Study population. Similarly vaccinated adults without symp-toms were enrolled as controls at two study centers Halifax and Vancou-ver.

To identify cases, participants were given an information card con-taining a list of ORS symptoms at occupational health-based influenzaimmunization clinics and were asked to call a study nurse by telephone ifthey experienced any of the listed symptoms after immunization. Adults who reported postimmunization symptoms were eligible ascases if they experienced symptoms consistent with ORS starting 4 to 48 hafter vaccination that were still present at the time of the first blood draw.

Control subjects those who were asymptomatic were recruited fromemployee immunization clinics. ORS cases were defined according to the National AdvisoryCommitteeon ImmunizationORScriteria 8 ,with the exclusionof thepres-ence of coryza, to minimize the possibility of enrolling cases with symptomsrelated to infection.

Adults were excluded if they had received blood or anyblood-derived productswithin the past 3months, had an active disease of theimmune system such as transplantation, HIV infection, or congenital im-TABLE 1 Clinical manifestations of ORSaSymptom type Specific symptomsOcular Bilateral red eyes conjunctival erythema Respiratory Cough, sore throat, hoarseness, wheezing,chest tightness, difficulty breathing,difficulty swallowingFacial edema Lip, tongue, or eyelid swellinga ORS cases can present with symptoms from one or more categories, and ORSsymptoms can be associated with other systemic manifestations.

One of the cases experienced ORS twice, and one had it once previously. Study procedures. A blood sample was drawn at visit 1 to measureinflammatory cytokines andHAI titers during the acute disease phase forcases or approximately 4 to 72 h postimmunization for controls. Asecond blood sample was obtained 21 to 28 days postimmunization visit2 to measure inflammatory mediators and HAI titers.

Case subjects weregivenmemory aids during the first visit to record the perceived severity asmild present, but does not interfere with daily activities , moderate in-terferes with daily activities, but does not prevent them , or severe pre-vents daily activities , date of maximum intensity, and duration of theirsymptoms for 7 days after vaccination.

They were also asked to record anyassociated general symptoms malaise, myalgia, arthralgia, fatigue, head-ache, rash, and itchiness and to document the occurrence of any newsymptoms, including a runny nose, after the first visit. Cases werecontacted by telephone 7 days after vaccination for safety debriefingand to assess the resolution of symptoms. Those with ongoing symp-toms were asked to continue documenting their symptoms, and theirrecords were collected at the second visit.

A third blood sample wasdrawn to measure select inflammatory cytokines 9 to 12 months afterTIV immunization. Blood sample processing. Samples were transferred between sites on dry ice. Laboratory personnel were blinded to the case and control statuses of theparticipants. Paired samples were analyzed concurrently.

Cases: 25 screened fromVancouver 0 screened fromHalifaxControls: 27 recruited fromHalifax 10 recruited fromVancouver10 Cases enrolled 37 Controls enrolledTotal 9 cases included inthe final analysis1 withdrawal: 2nd bloodsample was not obtained2 withdrawals: 1st bloodsample was not obtainedTotal 35 controls includedin the final analysisTotal 44 subjects included in the final analysis FIG 1 Included cases and controls. Al-Dabbagh et al. Undetectable cytokines wereassigned a value of half the minimal level of detection.

Hemagglutination inhibition test HAI. Statistical analysis. Descriptive statistics were used to report the base-line characteristics of the participants. The primary outcome of the study was the difference inmean individ-ual blood plasma cytokine concentrations between ORS cases and con-trols at visit 1. Logarithmic transformations were used prior to analysisto ensure the assumptions of normality, and comparison was done usinga two-sample t test.

For the primary outcome, significancewas determined using a Bonferronicorrection for the adjustment ofmultiple comparisons; an alpha of 0. The secondary outcomewas themean difference inHAI titers betweenvisit 1 and visit 2 for cases and controls. Logarithmic transformation togeometric mean titers GMT was done to meet a normality assumption,and the two-sample t test was used.

Dataanalysis was done using SAS 9. NineORS cases and 35 controls wereenrolled Fig. All cases came fromone center Vancouver ,where the study informationwas provided to 3, immunized indi-viduals. Themean time from vaccination to the first blood drawwassimilar in cases and controls Baselinecharacteristicswere similarbetweencases andcontrolsin all clinical categories Table 2.

Description of AEFI symptoms. Among the nine ORS cases,the most commonly reported symptom was chest tightness, fol-lowed by sore throat, hoarseness, and cough Table 3. ORS symp-toms ranged frommild tomoderate in severity and were generallywell tolerated.

One case who rated her symptoms as moderatereported staying at home for 4 days due to symptoms. None of the ORS cases sought medical advice or required hospi-talization. Most of these casesrated their symptoms as mild or moderate, with only four report-ing severe symptoms two with headache, one with malaise, andone with itchiness. Description of study outcomes. Open circles represent outliers, which are values more than 1.

None of the other 36 cytokine concentration levels evaluated werefound to be elevated in cases compared with controls. Seven ORS cases had an additionalblood draw 9 to 12months after vaccination tomeasure IL andIL-3 concentrations; no change in the mean cytokine levels wasevident data not shown. To determine if certain cytokine concentrations were acutelyelevated following vaccination in both cases and controls, themean difference in measured values between the first and secondsamples was computed for all 39 measured cytokines.

No signifi-cant change including decline in values was evident with anycytokine data not shown. Seroprotection rates were similar in cases and controls for all threestrains contained in the influenza vaccine. In general, the baselineseroprotection rate was higher for the B strain than the A strain inboth cases and controls. However, the cytokines that were elevated insymptomatic ORS cases were still high 21 to 28 days and 9 to 12months later. This suggests that the symptoms of ORS in affectedsubjects were not due to a sudden increased production of inflam-matory cytokines in response to influenza vaccination.

Instead,elevated concentrations of these cytokines may represent a bio-marker for susceptibility to ORS without necessarily playing adirect role in its pathogenesis. Open circles represent outliers,which are values more than 1. The increase in cytokinesmaybe related to genetically determined differences in the baselineproduction of these two cytokines. IL-3 has been describedto play an important role in inducing chronic inflammation bysupporting cell-mediated immune responses, and it is also in-volved in eosinophil activation, B-cell differentiation, and controlof IgE synthesis In contrast, IL is a potent anti-inflamma-tory cytokine with several important immunoregulatory func-tions IL also has an anti-inflammatory effect on eosinophils, basophils, andmast cells, andthus, it plays a major role in the control and regulation of allergyand asthma 12, It is thus difficult to implicate these cytokinesin specific cause-and-effect relationships with ORS.

An association between host genetic factors and the develop-ment of AEFI has been hypothesized 14— Stanley et al. In addition, Vestergaard et al. Our study was exploratory, and its major limitation is itssmall sample size. Our numbers in this pilot study were insuf-ficient to detect all but the greatest differences between casesand controls for most cytokines. The reliance on self-reportingof ORS symptoms is another limitation of our study.

This lim-ited our ability to identify all ORS cases that occurred duringthe campaign season. It is unclear to us why no ORS cases weredocumented in Halifax, as the same vaccine was used in bothprovinces; this may be due to an actual difference in the inci-dence of ORS between Nova Scotia and British Columbia anddeserves further investigation.

Finally, although our propor-tion of females to males was not significantly unbalancedamong cases and controls, female predominance in ORS caseshas been documented in all previous reports 1—3, 8, 16, 18 ,and the effect of gender should be examined in future studies.

This study demonstrates that in adults with ORS, a persis-tent elevation in blood plasma levels of specific cytokines IL and IL-3 compared to vaccine recipients without ORScan be detected. The persistent nature of the elevation suggeststhat underlying host factors may predispose certain individualsto develop ORS following influenza vaccination. Given the ex-ploratory nature of our data, further investigation of these phe-nomena in a study with a larger sample size may be warranted.

Only one centre used both Agriflu and Vaxigrip, in unknown proportions and was excluded from this sub-analysis. Validity of self-reported events by healthcare personnelParticipants who reported any severe health event i. Participants were allowed to enter several health events of interest occurring during the week, but nurses were required to choose a single primary event i.

Respiratory or gastrointestinal symptoms were considered the primary event when reported in conjunction with systemic symptoms. A minimum of five attempts to contact each non-responder was made on different days and at different times before another non-responder was selected. Overall, 15, For the control questionnaire, 12, HCW immunised during the previous season were contacted in and 9, in , with response rates of Demographic characteristics of controls and vac-cinees are shown in Table 1.

Observed health events and capacity for signal investigationOver the two study years, 1, 9. Among vaccinated HCW, reported events 2. Overall, However, sys-temic symptoms were more frequently reported by vac-cinated HCW The hospitals surveyed in this study conducted their yearly vaccinations campaigns earlier than most juris-dictions in Canada and HCW at one of these hospitals were vaccinated with the vaccine implicated in the safety concern before it was temporarily suspended.

This allowed a comparative safety review of the sig-nal vaccine severe event rates with the other seasonal influenza vaccines and the background rates observed in controls within 48 hours of the vaccine suspension. This confirmed the interim findings. The rate of self-reported severe events among HCW vaccinated with the signal vac-cine was 2. The clinical nature of severe health events reported by HCW vaccinated with the signal vaccine was similar to those reported after other seasonal vaccines Figure.

Participants who were excluded did not vary according to the type of event or clinical presentation, with the notable exception of paraesthesia, which was a pre-existing condition in all controls not considered. The accuracy and validity of the online reported severe health events are shown in Table 3.

Among validated severe events Most medical consultations were clinic visits At the time of follow-up, the reported problem had either resolved In the two seasons under study, one participant was hospitalised in the week fol-lowing vaccination for gastrointestinal symptoms that started six hours after vaccination. This individual was diagnosed with appendicitis resulting in an emergency appendectomy. No deaths were reported. Representativeness of events reportedStudy participants who did not respond to the online questionnaire i.

Vaccinated participants who responded online reported more health events 9. The rate of severe events, however, was generally similar in both responders and initial non-responders. Vaccinee non-responders reported not answering the online ques-tionnaire due to circumstantial factors, mainly because they reported being too busy DiscussionOnline monitoring offers an economical and sustainable platform to conduct large-scale electronic surveillance of vaccinated individuals, allows rapid identification of AEFI and minimises human resource needs.

However, rapid large-scale surveillance of vaccine safety poses challenges which require a careful balance between information needs and feasibility. The quantity and validity of the information collected must be sufficient to allow stakeholders to detect and interpret safety signals in a timely manner, while requesting a minimal amount of information to obtain sufficient response rates from participants. As shown during the influenza A H1N1 pdm09 pandemic, internet-based safety questionnaires are uniquely suited to rapid collection and analyses and can be adapted to provide monitoring for seasonal influenza vaccines [3,].

The rapid collections of data, early in the mass vaccination campaigns that occur simultaneously across Canada allow for ongoing monitoring and analysis throughout the first weeks of activities and provides an opportunity to detect signals before widespread vaccine use. The ability of online surveillance to detect rare events will depend on the total number of respondents.

Our study was able to detect events with a frequency of 1 per 1, Although public health officials were concerned about the possibility of an increase in oculorespiratory syn-drome among Agriflu recipients in , event rates observed among HCW vaccinated in centres using this vaccine were similar to the rates observed in centres using other seasonal vaccines and to rates observed in the control group. The interim analysis of data, in response to the temporary suspension of the Agriflu vaccine, confirmed that the network can provide timely evaluation of safety signals and adequately support decision makers.

At this time, our network remains the largest able to provide active monitoring of influ-enza vaccine safety both nationally and internation-ally. Our findings confirm that influenza vaccines used in Canada for both the and seasons were safe and that their safety profiles were consistent with those expected following influenza vaccination. We also showed that most of the eligible severe events self-reported by vaccinated HCW were consistent with the nurse interviews and had indeed prevented daily activities, resulted in missed work or required a medi-cal consultation.

The higher error rate in the control questionnaire reflects the difficulty controls may have in identifying the time period under surveillance and indicates a reference point, through a reminder email, may be needed for this group. Vaccinees have the advantage of a well-defined observation period start-ing at the vaccination event from which to start tracking any new or exacerbated symptoms.

This discrepancy was particularly evident for the paraesthesia ques-tions where control symptoms starting more than one week before the questionnaire period were frequently reported, indicating background rates for chronic con-ditions or illness may be more difficult to separate from new events using an online questionnaire.

This short-coming was addressed in the severe event follow-up where the difference between controls and vaccinees disappeared when more accurate questioning elicited precise event windows. Reassuringly, most primary diagnoses had indeed been reported by participants, but the main difficulty we encountered in validating health events reported by both controls and vaccinated HCW was in distinguishing the primary complaint from all other health events that occurred during the obser-vation period.

This problem was particularly evident for local reactions and systemic symptoms, which often accompanied respiratory and gastrointestinal symp-toms, but which alone did not prevent daily activities or lead to absenteeism or medical consultations. The more specific events or symptom questions on the online questionnaire respiratory symptoms, gastro-enteritis, etc. The inclusion of a control group in our study is an added strength of the network.

It provides background rates for health events just before the start of the influenza vaccination campaign in a similar popula-tion and enables precise calculation of risk estimates. Moreover, age and sex specific background rates can be estimated. Importantly background event rates can be compared over multiple years to address fluc-tuations in events or temporal variations, a potential weakness of the staggered data collection periods of controls and vaccinees.

The similarity in severe event rates between initial non-responders and online responders indicates our online survey participants were representative of their respective vaccine and control groups. This suggests the rates of severe events elicited with our online sur-vey is representative of the group overall. LimitationsWe did not track the total number of individuals who presented at each institution for vaccination or the characteristics of those who were vaccinated but did not enrol in our study.

Therefore, we cannot determine whether selection bias occurred at recruitment. Even if our sample is not representative of all HCW, we would not expect the rate of severe events to occur differen-tially among those who participated and those who did not. In our control group, we had fewer controls that were under the age of 30 years, but the proportion in the remaining age categories was similar, therefore we would not expect this to affect our estimates for severe events.

Moreover our severe event rates mirror those seen in other studies collected by different methods [11,14]. The importance of individual-level vaccine informa-tion became immediately apparent with the temporary suspension of one vaccine product. Fortunately for our study, only one among the healthcare centres consid-ered used multiple influenza vaccines, so we were able to infer which product individuals received based upon where they were immunised.

However, our experience from institutional vaccination of HCW using a single 9www. In subsequent years, as a wider range of vaccine products become available, individual-level vaccine product data will be necessary. HCW who participated in our surveillance constitute a unique group of vaccine recipients, which may not be representative of community vaccinees.

This likely enables them to better evaluate health problems and communicate chief com-plaints which may have improved the validity of the online survey. The validity of self-reported events by non-HCW populations may not be similar. Evaluation of this methodology in cohorts of children and non-HCW adults are needed.

ConclusionsOnline surveillance can provide rapid assessment of influenza vaccine safety and is highly acceptable to the HCW participating in this activity. The addition of a control group enhances internal validity and estab-lishes background rates for common events of interest.

This methodology works particularly well in a mass vaccination setting where large numbers of individuals can be rapidly enrolled and followed-up and meets the new enhanced surveillance requirements as outlined by the EMA. The funders had no role in this study. The authors gratefully acknowledge the expert assistance pro-vided by the Vaccine Evaluation Center, public health and hospital collaborators, the study site coordinators, research nurses and research staff.

Conflict of interestJAB none. IR none. MCG none. WRB none. LV received re-search grants from Pfizer and Cubist, consultation fees from Cubist and is involved in sponsored clinical trials with Merck and Sanofi. JDK none. BLC none. AM none. IR was involved in the conception and design of the study, the analysis and interpretation of the data, and writing and revision of the manuscript. MCG was involved in the acquisition of the data, the analysis and interpretation of the data, and writing and revision of the manuscript.

WRB was involved in the design of the study, acquisition of the data and revision of the manuscript.

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If this effect is representative of the entirecountry, 75—85 IMD cases and 10—12 deaths will have been pre-vented in Canada annually [10]. There has been no evidence ofserogroup replacement overall, and a reduction in disease in allprovinces irrespective of the schedule used, suggesting that thedoses at 12 months and in adolescence may be the most impor-tant and perhaps sufficient since these were almost universallyincluded in immunization schedules.

This study has providedclear evidence that this vaccine likely induced herd immunityby reducing the transmission of N. In Europe there was a fold drop inthe incidence of serogroup C IMD in the 4—7 years after vaccineintroduction in 6 countries [11]. These countries used 2—3 dosesin infants or a single dose at 12 months, with a catch-up cam-paign and no routine adolescent dose.

This was subsequently changed to 2 infant dosesplus a month dose, similar to the initial schedule used in Al-berta. The decrease in the United Kingdom is similar to Canadain provinces where such longer-term data are available. In theNetherlands, children receive a single dose of MCCV at 14months of age, although a catch-up campaign of all childrenup to 18 years was undertaken when MCCV was introduced—similar to the program in Quebec.

Sim-ilar successes have also been achieved in Spain and Australia,but neither of these countries use an adolescent dose [14]. MCCV has been a highly successful vaccine globally, in largepart due to its ability to induce herd immunity by reducing na-sopharyngeal carriage of N. Inclusion of an adolescent dose of vaccine to includethis age group has therefore been a critical strategic decisionduring vaccine implementation. Although the presence of aroutine adolescent dose should maintain population herd im-munity, the effect of a 1-off catch-up campaign has the potentialto diminish over time due to waning of immunity in those im-munized as young children [13].

The cases of disease in vacci-nated individuals in this study confirm what others havedemonstrated regarding persistence of immunity following vacci-nation with MCCV. This is similar to data from the United King-dom, where there were 53 cases in vaccinated children [16] in thefirst 3 years after introduction of MCCV of a total of se-rogroup C cases 4. In the majority of children, protec-tion following doses in early infancy does not persist beyond 12months of age [18], whereas immunity is maintained for 1—2years after a dose at 12 months of age [13], 2—5 years for thosevaccinated between 1 year and 9 years of age, and at least 5years if vaccinated when 10 years or older [19—22].

All provinces and territories in Canada have had a routineadolescent meningococcal vaccine dose in place since ,with the exception of Alberta introduced in and Quebec This should ensure the current low incidence of se-rogroup C disease in Canada persists, as long as the highTable 2. Cases 2—4 occurred in children who only received 2doses of MCCV in infancy and missed the month booster, developing IMD 2—3 years after their last dose of vaccine.

Cases 5 and 6 only received a single month dose of vaccine and developed disease 1—2 years subsequent to that. Cases 7—9 received a single dose as older children and developed IMD 5—6 years later. Most cases occurred in the first 3—4 years after introduction of MCCV program into a province. This appears particularly relevant to serogroup C because thehighest incidence rate was observed in the 15—24 year agegroup. In Europe only Austria, Switzerland, and the UnitedKingdom currently have a routine adolescent dose [23, 24].

The importance of the adolescent booster is also suggested inthis study with 4 cases in Alberta in occurring in unvacci-nated individuals in this age group, where the adolescent dosewas introduced in , 8 years after MCCV was introduced.

Itwill be important to observe whether serogroup C IMD re-emerges in those countries where incidence was previouslyhigh and an adolescent dose is not used. The major strengths of this study are that it was based on ac-tive, population-based surveillance to maximize case ascertain-ment and provides accurate estimates of disease incidence. Inclusion of several provinces and various MCCV scheduleshas enabled comparison of the different strategies, which canbe used to inform future policy decisions in Canada and inter-nationally.

The study also has some limitations. Some individ-uals with IMD residing within the defined study populationarea may have attended hospitals outside the IMPACT network,leading to an underestimate of disease incidence. If individualswere too sick to have appropriate samples taken early in theirillness or they died before samples could be obtained, the bac-terium would not be isolated, and such cases would be excluded.

The study population areas are generally in urban areas, so datafrom cases in rural areas were limited. Although it is possiblethat epidemiology may be different in rural Canada, trendsare similar to data collected by the National Enhanced InvasiveMeningococcal Disease Surveillance System [10], suggestingthat these results are a true reflection of Canadian epidemiology. Systematically collected vaccine uptake data were not availableto include in the analyses to provide further support to the con-clusion that reduction in serogroup C disease was due to imple-mentation of MCCV.

The number of cases of serogroup C IMD is relativelysmall, particularly in the 6 month to 2 year age group. However, statistical signifi-cance was still achieved for most of the analyses, suggestingthat effects were large enough for robust conclusions to bedrawn.

The reduction of serogroup C IMD has been a great successstory for immunization. The variable implementation of MCCVin different provinces has provided a unique opportunity tocompare different policies and as data have emerged aboutthis vaccine, so the vaccination strategies have evolved.

Follow-ing the successful control of serogroup C IMD, future attentionwill focus on reduction of disease caused by other serogroups,primarily serogroup B, which is now the leading cause of IMDin Canada [30]. A new vaccine based on subcapsular proteinsfound within the bacterial outer membrane has recently beenlicensed in Europe [31] and Canada www.

Quad-rivalent meningococcal conjugate vaccines for serogroups A, C,Y, and W are currently used in several provinces and territoriesas the adolescent dose as an alternative to MCCV. Adequate in-dividual surveillance, particularly in childhood, is also neededto maintain the current low rates of serogroup C disease, to en-sure children receive all recommended doses.

Supplementary materials consist of data pro-vided by the author that are published to benefit the reader. The posted ma-terials are not copyedited. The contents of all supplementary data are thesole responsibility of the authors. Questions or messages regarding errorsshould be addressed to the author. They thankthe Directors and staff of the provincial and territorial public health labora-tories for providing the isolates for this study.

Financial support. The funders had no role in study design, data collection and analysis,decision to publish, or preparation of the article. Potential conflicts of interest. All other authors report noconflicts. Conflicts that the editors consider relevant to the con-tent of the manuscript have been disclosed.

World Health Organization. Control of epidemic meningococcal dis-ease: WHO practical guidelines. Geneva, Switzerland: WorldHealth Organization, The Stonehouse sur-vey: Nasopharyngeal carriage of meningococci and Neisseria lactamica. Epidemiol Infect ; — Asymptomatic carriage ofNeisseria meningitidis in a randomly sampled population. J Clin Micro-biol ; — An update on the invasive meningococcal disease and meningococcalvaccine conjugate recommendations.

Enhanced surveillance of invasive me-ningococcal disease in Canada: 1 January, , through 31 December, Can Commun Dis Rep ; — Statement on recom-mended use of meningococcal vaccines. Can Commun Dis Rep ;— Meningococcal vaccine for children. Paediatr Child Health ; —9. Statistics Canada. Accessed 29 November The changing epidemiology ofmeningococcal disease in Quebec, Canada, — Potential impli-cations of emergence of new strains.

PLoS One ; 7:e Public Health Agency of Canada. Accessed 21 January Ramsay M, Fox A. Invasive Neisseria meningitidis inEurope London: Health Protection Agency, Updated post-licensure surveillance of the meningococcal C conjugate vaccine inEngland and Wales: Effectiveness, validation of serological correlatesof protection, and modeling predictions of the duration of herd immu-nity.

Clin Vaccine Immunol ; —7. Is a single dose of meningococcal serogroup C conjugate vaccine suffi-cient for protection? Experience from the Netherlands. BMC Infect Dis; Epidemiology and prevention of meningo-coccal disease: A critical appraisal of vaccine policies. Expert Rev Vac-cines ; — Maintaining protection against in-vasive bacteria with protein-polysaccharide conjugate vaccines. Nat RevImmunol ; — Clinical and immunologic risk fac-tors for meningococcal C conjugate vaccine failure in the United King-dom.

J Infect Dis ; — Public Health England. Meningococcal Reference Unit Laboratory con-firmed reports. Accessed 5 December Effec-tiveness of meningococcal serogroup C conjugate vaccine 4 years afterintroduction. Lancet ; —7. Maintenance of immune re-sponse throughout childhood following serogroup C meningococcalconjugate vaccination in early childhood. Clin Vaccine Immunol; — Antibody persistence after se-rogroup C meningococcal conjugate immunization of United Kingdomprimary-school children in — and response to a booster: Aphase 4 clinical trial.

Clin Infect Dis ; — Investigation of serum bacter-icidal activity in childhood and adolescence 3—6 years after vaccinationwith a single dose of serogroup C meningococcal conjugate vaccine. Top-rated countries support their immunization programs in additional ways, some of which may be helpful in Canada.

In the United States, a national recommendation to use a new vaccine automatically trig-gers a number of federal, state and private-sector funding mechan-isms, ensuring universal access to the vaccine. School entry requirements in nearly all states demonstrate a commitment to the value of childhood immunization and encourage compliance.

All rights reservedCommentaryPaediatr Child Health Vol 19 No 5 May Australia, the state signals its commitment to childhood immun-ization by linking child benefit payments to evidence of schedule compliance unless a medical exemption exists. In contrast, the low-key promotion of childhood immunization in Canada fails to convey a deep societal commitment to its extraordinary value.

The UNICEF report must be taken seriously: improvements are urgently needed in immunization services and coverage rates. It is not about improving the national ranking per se but bettering infection prevention measures among children at risk. We can and should do better, with the key steps being: achievement of a uni-form national immunization program; establishment of a suitable electronic immunization registry in every province and territory; and utilization of registries and other methods to closely monitor and publicize coverage rates, leading to remedial action where rates are low.

Other strategies to encourage timely immunization that have been successful in top-rated countries should also be considered. Child well-being in rich countries: A comparative overview. National standards for immunization coverage assessment: Recommendations from the Canadian Immunization Registry network.

Can Commun Dis Rep ; Public Health Agency of Canada. Canadian National Report on Immunization, Stuck in the Middle. Share link DOI :. Customize your widget with the following options, then copy and paste the code below into the HTML of your page to embed this item in your website. Include Metadata Specify width in pixels leave blank for auto-width :. Our image viewer uses the IIIF 2.

Scheifele, David W. Halperin, Scott A. Bettinger, Julie A. Vancouver : University of British Columbia Library. Attribution-NonCommercial-NoDerivs 2.

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Julie bettinger ubc library The drug was developedand used in Nazi prison camps and fed to Canadians post war. Influenza Other Respir Viruses. McNeil and I. Influenza infection is a major cause of morbidity and mortal-ity worldwide, and vaccination is the cornerstone of infectionprevention. All questionnaires received byOctober 29after the first questionnaire mailing,were included in this report. The rate of self-reported severe events among HCW vaccinated with the signal vac-cine was 2. Biography I am a vaccine safety scientist at the Vaccine Evaluation Center, a leading center for applied vaccine research in Canada.
Espn first take patriots bengals betting Relevant Degree Programs. October 13, Compose an error-free and grammatically correct email addressed to your specifically targeted faculty member, and remember to use their correct titles. Scheifele, David W. TABLE 1. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Studies of attitudes of both HCWs who worked at or-ganizations with mandatory vaccination or alternative programs such as mandatory vaccineor mask policies and those who worked at organizations with voluntary programs reflect simi-lar themes [39—41].
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Halperin is one of two Co-PIs for theveillance network. He was involved with conceptionof themeningococcal surveillance project and the studyre as well as data acquisition. He revised and approveded manuscript. She was involved with con-design of the meningococcal surveillance project, theted here and data acquisition. She revised and approvededmanuscript. Medini provided access to and explanationatory and statistical methods used in the Plikaytis et al.

Heapproved the submittedmanuscript. He was respon-e serogroup and sequencing typing of the serogroup Bwas involvedwith interpretationof thedata. He reviseded the submitted manuscript. DM: employee Novartis Vaccines. RT: None. Raymond Tsang,icrobiology Laboratory, Winnipeg, Canada. Ben Tan,ersity Hospital, Saskatoon, Canada. Taj Jadavji, Albertaospital, Calgary, Canada.

CanDis Rep ;— The dis-en of invasive meningococcal serogroup B disease in Canada. PediatrJ ;e20—5. Cell adhesion molecules. Science ;—7. Antigenic similarities between brain compo-bacteria causing meningitis. Implications for vaccine developmentogenesis. Lancet ;—7. Reverse vaccinology. Curr Opin Microbiol ;— Meningococcal protein antigens and vaccines.

Choosing isolates for the evaluation of meningococcalprotein vaccines. Expert Rev Vaccines ;—3. The newmulticomponent vaccine against meningococcal serogroup B, 4CMenB:immunological, functional and structural characterization of the antigens. Vac-cine ;30 Suppl. Biggest advance against meningitis in 30 years: new jab approvedwhich could save thousands of lives.

London: Mirror; Vaccine ;—9. Fromtailor-made to ready-to-wear meningococcal B vaccines: longitudinal study ofa clonal meningococcal B outbreak. Lancet Infect Dis ;— Propertiesand clinical performance of vaccines containing outer membrane vesicles fromNeisseria meningitidis. Vaccine ;27 Suppl.

SerogroupBmeningococcal vaccines — anunfinishedstory. Advances in thedevelopment of vaccines againstNeisseria meningitidis. N Engl J Med ;— Quali-tative and quantitative assessment of meningococcal antigens to evaluate thepotential strain coverage of protein-based vaccines. Invasiveserogroup B Neisseria meningitidis in Quebec, Canada, to persis-tence of the ST clone since it first emerged in J Clin Microbiol;— The chang-ing epidemiology of meningococcal disease in Quebec, Canada, —potential implications of emergence of new strains.

Paediatr Child Health ;—5. The impact ofchildhood meningococcal serogroup C conjugate vaccine programs in Canada. Pediatr Infect Dis J ;—4. Profile of serogroup Y meningococcal infections in Canada: implications forvaccine selection. Mul-tilocus sequence typing: a portable approach to the identification of cloneswithin populations of pathogenic microorganisms.

In: Oxford Uo, editor. Neisseria Multi Locus SequenceTyping website. Wellcome Trust and European Union; Characterization of fHbp, nhba gna , nadA, porA, andsequence type in group B meningococcal case isolates collected in Englandand Wales during January and potential coverage of an investiga-tional group B meningococcal vaccine.

Clin Vaccine Immunol ;— Distri-bution and genetic variability of three vaccine components in a panel ofstrains representative of the diversity of serogroup B meningococcus. Interlaboratory standardization of the sandwich enzyme-linkedimmunosorbent assay designed for MATS, a rapid, reproducible methodfor estimating the strain coverage of investigational vaccines.

Clin VaccineImmunol ;— PRe-dicted strain coverage of a meningococcal multicomponent vaccine 4CMenB inEurope: aqualitative andquantitative assessment. Lancet InfectiousDiseases; in Press. The panmictic nature of Neisseria meningitidisserogroup B during a period of endemic disease in Canada. Can J Microbiol;—9. In: 18th international pathogenic Neisseria conference, P Wurzburg, Germany: University of Wurzburg; In the NadR regulon, adhesins anddiverse meningococcal functions are regulated in response to signals in humansaliva.

J Bacteriol ;— Putativevaccine antigens from Neisseria meningitidis recognized by serum antibod-ies of young children convalescing after meningococcal disease. J Infect Dis;— The challenge ofpost-implementation surveillance for novel meningococcal vaccines. Vaccine;30 Suppl.

Share link DOI :. Customize your widget with the following options, then copy and paste the code below into the HTML of your page to embed this item in your website. Include Metadata Specify width in pixels leave blank for auto-width :. We explored whether children who reside with their biological father have better health than children whose fathers live elsewhere. We found that children with non-co-resident fathers were not at higher risk of these health outcomes. We used total information functions to assess the precision of father involvement estimates.

Most fathers were reportedly spending time with infants, doing routine care activities and providing financially. Fewer fathers were involved in important care decisions or doing household chores. For most fathers in the sample, the questionnaire gave precise estimates of involvement in three modes of care: Accessibility, Direct Caregiving, and Practical Support for Mother.

In contrast, items measuring Material Provisioning and Responsibility gave imprecise estimates for the majority of fathers. Our findings reinforce existing evidence that co-residence status is an inadequate proxy for care involvement. With further validation, the questionnaire assessed in this study could be used to measure the more direct modes of infant care. View record. The primary objective was to determine whether HEU infants experience greater infectious morbidity than HUU infants through HIV exposure-specific pathways beyond universal infant morbidity risk factors.

Methods: This prospective cohort study identified low risk HIV-infected and HIV-uninfected mothers and their term newborns from a single community midwife unit in Kraaifontein, South Africa. The primary outcome, at least one infectious cause hospitalization or death before six months of age, was classified according to modified WHO case-definitions and compared between HEU and HUU infants.

Complete outcome determination on all infants was possible through linkage with the electronic provincial hospital administration system and mortality registry. Adjusted odds ratios aOR were calculated by multivariable logistic regression including stratified analyses conditioned on breastfeeding. HIV-infected mothers were older median Skip to main content Skip to main navigation. Graduate and Postdoctoral Studies Graduate School.

Julie Bettinger. Associate Professor. Faculty of Medicine. Research Classification Public and population health. Research Interests Epidemiology. Relevant Degree Programs. Population and Public Health, Master of Science. Population and Public Health, Doctor of Philosophy. View all programs. Biography I am a vaccine safety scientist at the Vaccine Evaluation Center, a leading center for applied vaccine research in Canada.

Research Methodology Epidemiology. Recruitment Looking to recruit: Master's students. Desired start dates: Potential research project areas: Vaccine preventable disease epidemiology, vaccine safety, vaccine hesitancy, both qualitative and quanitative methodologies. Other options: I support public scholarship, e.

I support experiential learning experiences, such as internships and work placements, for my graduate students and Postdocs. I am open to hosting Visiting International Research Students non-degree, up to 12 months. Complete these steps before you reach out to a faculty member! Check requirements.

MCLEANS GAA CLUB MATCH BETTING

Jadavji and O. Vanderkooi and D. Scheifele and L. Sauve and J. Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, and Eurosurveillance Bettinger, J. Law and Wendy Vaudry and Scott A. Halperin and Julie A. Kellner DOI: Bettinger and N.

Bettinger and Dat Tran and Scott A. Halperin and David W. Scheifele DOI: Slogrove and J. Canada Communicable Disease Report Applicability of the Brighton Collaboration Case Definition for seizure after immunization in active and passive surveillance in Canada Vaccine Karina A. Top and Cora M. Bettinger and David W. Scheifele and Wendy Vaudry and Scott A. Halperin and Barbara J. Law DOI: Scheifele and Shelly A. McNeil and Brian J. Bettinger and Scott A.

Immunizing health care workers against influenza: A glimpse into the challenges with voluntary programs and considerations for mandatory policies American Journal of Infection Control Susan Quach and Jennifer A. Pereira and Jeffrey C. Pereira and Christine L. Heidebrecht and Jeffrey C. Vaccine hesitancy: An overview. Scheifele and Tobias R. Kollmann and Scott A. Halperin and Joanne M. Langley and Julie A. Al-Dabbagh and K. Lapphra and D. Halperin and J. Langley and P.

Cho and T. Kollmann and Y. Li and G. Fortuno and J. Measuring influenza immunization coverage among health care workers in acute care hospitals and continuing care organizations in Canada American Journal of Infection Control Susan Quach and Jennifer A. Pereira and Jemila S. Hamid and Lois Crowe and Christine L. Kwong and Maryse Guay and Natasha S.

Chambers and Sherman D. Quan and Julie A. How best to describe the risk of meningococcal B infection? Determinants of parents' decision to vaccinate their children against rotavirus: results of a longitudinal study Health Education Research E.

Dube and J. Bettinger and B. Halperin and R. Bradet and F. Lavoie and C. Sauvageau and V. Gilca and N. Boulianne DOI: Evaluation of meningococcal serogroup C conjugate vaccine programs in Canadian children: Interim analysis Vaccine Julie A. Kellner and Otto G.

Gilca and C. Sauvageau and J. Bettinger and F. Boucher and S. McNeil and I. Gemmill and F. Lavoie and M. Ouakki and N. Slogrove and B. Reikie and S. Naidoo and C. De Beer and K. Ho and M. Cotton and J. Bettinger and D. Speert and M. Esser and T. Kollmann DOI: The changing and dynamic epidemiology of meningococcal disease Vaccine Scott A. Bettinger and Brian Greenwood and Lee H.

Harrison and Jane Jelfs and Shamez N. Ramsay and Marco A. Exploring the feasibility of integrating barcode scanning technology into vaccine inventory recording in seasonal influenza vaccination clinics Vaccine Jennifer A. Pereira and Susan Quach and Jemila S. Hamid and Christine L. Heidebrecht and Sherman D. Buckeridge and Julie A. Bettinger and Donna Kalailieff and Jeffrey C. Kwong DOI: Sauvageau and R.

Bradet and J. Boulianne and F. Lavoie DOI: Boucher and Julie A. Time and motion study to compare electronic and hybrid data collection systems during the pandemic H1N1 influenza vaccination campaign Vaccine Susan Quach and Jemila S. Hamid and Jennifer A. Heidebrecht and Julie Foisy and Julie A. Bettinger and Laura Rosella and Natasha S.

Crowcroft and Shelley L. Deeks and Sherman D. Quan DOI: Approaches to immunization data collection employed across Canada during the Pandemic H1N1 influenza vaccination campaign Canadian Journal of Public Health Halperin and Wendy Vaudry and David W.

Acceptability of Internet adverse event self-reporting for pandemic and seasonal influenza immunization among health care workers Vaccine Keswadee Lapphra and Simon Dobson and Julie A. Bettinger and Laura J. Greenberg and Martha Doemland and Julie A. The effect of routine vaccination on invasive pneumococcal infections in Canadian children, Immunization Monitoring Program, Active — Vaccine Julie A.

Scheifele and James D. Kellner and Scott A. Why collect individual-level vaccination data? Rotavirus vaccination: results of a longitudinal study on determinants of Canadian parents' decision Canadian Journal of Infectious Diseases and Medical Microbiology Canadian family physicians' and paediatricians' opinions and intentions regarding hepatitis A and B infection and their prevention by vaccination Canadian Journal of Infectious Diseases and Medical Microbiology Surveillance for adverse events following adjuvanted pandemic influenza vaccine in Canadian children Canadian Journal of Infectious Diseases and Medical Microbiology Priorities for new vaccination programs implementation: paediatricians' and family physicians' opinions Canadian Journal of Infectious Diseases and Medical Microbiology Rotavirus serotypes results from an impact emergency department study Canadian Journal of Infectious Diseases and Medical Microbiology Canadian family physicians' and paediatricians' opinions toward A H1N1 pandemic vaccine before and after vaccination campaign onset Canadian Journal of Infectious Diseases and Medical Microbiology Clinic staff perceptions of data collection methodologies used during the H1N1 influenza campaign in Canada Canadian Journal of Infectious Diseases and Medical Microbiology Approaches to immunization data collection employed across Canada during the H1N1 vaccination campaign Canadian Journal of Infectious Diseases and Medical Microbiology Time and motion study to compare electronic and hybrid data collection systems during the pandemic H1N1 influenza vaccination campaign Canadian Journal of Infectious Diseases and Medical Microbiology Acceptability of web-based influenza immunization adverse event self-reporting among health care workers American Journal of Epidemiology Rotavirus testing and admitting practices in 12 pediatric hospitals: implications for surveillance American Journal of Epidemiology Hospital acquired rotavirus infections: substantial disease burden in Canadian Pediatric hospitals Child: care, health, and development Scheifele and Julie A.

Influenza vaccination in paediatric nurses: Cross-sectional study of coverage, refusal, and factors in acceptance Vaccine Seamus P. Norton and David W. Bettinger and Robert M. West DOI: Burgess and Aaron F. Hirschfeld and Gregory J. Tyrrell and Julie A. Bettinger and Stuart E. Turvey DOI: Scheifele and Julie Bettinger and David M. Tyrrell DOI: Prevalence of Toll-like receptor signalling defects in apparently healthy children who developed invasive pneumococcal infection Clinical Immunology Aaron F.

Hirschfeld and Julie A. Participants who were excluded did not vary according to the type of event or clinical presentation, with the notable exception of paraesthesia, which was a pre-existing condition in all controls not considered. The accuracy and validity of the online reported severe health events are shown in Table 3.

Among validated severe events Most medical consultations were clinic visits At the time of follow-up, the reported problem had either resolved In the two seasons under study, one participant was hospitalised in the week fol-lowing vaccination for gastrointestinal symptoms that started six hours after vaccination.

This individual was diagnosed with appendicitis resulting in an emergency appendectomy. No deaths were reported. Representativeness of events reportedStudy participants who did not respond to the online questionnaire i. Vaccinated participants who responded online reported more health events 9. The rate of severe events, however, was generally similar in both responders and initial non-responders. Vaccinee non-responders reported not answering the online ques-tionnaire due to circumstantial factors, mainly because they reported being too busy DiscussionOnline monitoring offers an economical and sustainable platform to conduct large-scale electronic surveillance of vaccinated individuals, allows rapid identification of AEFI and minimises human resource needs.

However, rapid large-scale surveillance of vaccine safety poses challenges which require a careful balance between information needs and feasibility. The quantity and validity of the information collected must be sufficient to allow stakeholders to detect and interpret safety signals in a timely manner, while requesting a minimal amount of information to obtain sufficient response rates from participants.

As shown during the influenza A H1N1 pdm09 pandemic, internet-based safety questionnaires are uniquely suited to rapid collection and analyses and can be adapted to provide monitoring for seasonal influenza vaccines [3,]. The rapid collections of data, early in the mass vaccination campaigns that occur simultaneously across Canada allow for ongoing monitoring and analysis throughout the first weeks of activities and provides an opportunity to detect signals before widespread vaccine use.

The ability of online surveillance to detect rare events will depend on the total number of respondents. Our study was able to detect events with a frequency of 1 per 1, Although public health officials were concerned about the possibility of an increase in oculorespiratory syn-drome among Agriflu recipients in , event rates observed among HCW vaccinated in centres using this vaccine were similar to the rates observed in centres using other seasonal vaccines and to rates observed in the control group.

The interim analysis of data, in response to the temporary suspension of the Agriflu vaccine, confirmed that the network can provide timely evaluation of safety signals and adequately support decision makers. At this time, our network remains the largest able to provide active monitoring of influ-enza vaccine safety both nationally and internation-ally. Our findings confirm that influenza vaccines used in Canada for both the and seasons were safe and that their safety profiles were consistent with those expected following influenza vaccination.

We also showed that most of the eligible severe events self-reported by vaccinated HCW were consistent with the nurse interviews and had indeed prevented daily activities, resulted in missed work or required a medi-cal consultation. The higher error rate in the control questionnaire reflects the difficulty controls may have in identifying the time period under surveillance and indicates a reference point, through a reminder email, may be needed for this group.

Vaccinees have the advantage of a well-defined observation period start-ing at the vaccination event from which to start tracking any new or exacerbated symptoms. This discrepancy was particularly evident for the paraesthesia ques-tions where control symptoms starting more than one week before the questionnaire period were frequently reported, indicating background rates for chronic con-ditions or illness may be more difficult to separate from new events using an online questionnaire.

This short-coming was addressed in the severe event follow-up where the difference between controls and vaccinees disappeared when more accurate questioning elicited precise event windows. Reassuringly, most primary diagnoses had indeed been reported by participants, but the main difficulty we encountered in validating health events reported by both controls and vaccinated HCW was in distinguishing the primary complaint from all other health events that occurred during the obser-vation period.

This problem was particularly evident for local reactions and systemic symptoms, which often accompanied respiratory and gastrointestinal symp-toms, but which alone did not prevent daily activities or lead to absenteeism or medical consultations. The more specific events or symptom questions on the online questionnaire respiratory symptoms, gastro-enteritis, etc.

The inclusion of a control group in our study is an added strength of the network. It provides background rates for health events just before the start of the influenza vaccination campaign in a similar popula-tion and enables precise calculation of risk estimates.

Moreover, age and sex specific background rates can be estimated. Importantly background event rates can be compared over multiple years to address fluc-tuations in events or temporal variations, a potential weakness of the staggered data collection periods of controls and vaccinees. The similarity in severe event rates between initial non-responders and online responders indicates our online survey participants were representative of their respective vaccine and control groups.

This suggests the rates of severe events elicited with our online sur-vey is representative of the group overall. LimitationsWe did not track the total number of individuals who presented at each institution for vaccination or the characteristics of those who were vaccinated but did not enrol in our study. Therefore, we cannot determine whether selection bias occurred at recruitment.

Even if our sample is not representative of all HCW, we would not expect the rate of severe events to occur differen-tially among those who participated and those who did not. In our control group, we had fewer controls that were under the age of 30 years, but the proportion in the remaining age categories was similar, therefore we would not expect this to affect our estimates for severe events.

Moreover our severe event rates mirror those seen in other studies collected by different methods [11,14]. The importance of individual-level vaccine informa-tion became immediately apparent with the temporary suspension of one vaccine product.

Fortunately for our study, only one among the healthcare centres consid-ered used multiple influenza vaccines, so we were able to infer which product individuals received based upon where they were immunised. However, our experience from institutional vaccination of HCW using a single 9www. In subsequent years, as a wider range of vaccine products become available, individual-level vaccine product data will be necessary. HCW who participated in our surveillance constitute a unique group of vaccine recipients, which may not be representative of community vaccinees.

This likely enables them to better evaluate health problems and communicate chief com-plaints which may have improved the validity of the online survey. The validity of self-reported events by non-HCW populations may not be similar. Evaluation of this methodology in cohorts of children and non-HCW adults are needed.

ConclusionsOnline surveillance can provide rapid assessment of influenza vaccine safety and is highly acceptable to the HCW participating in this activity. The addition of a control group enhances internal validity and estab-lishes background rates for common events of interest. This methodology works particularly well in a mass vaccination setting where large numbers of individuals can be rapidly enrolled and followed-up and meets the new enhanced surveillance requirements as outlined by the EMA.

The funders had no role in this study. The authors gratefully acknowledge the expert assistance pro-vided by the Vaccine Evaluation Center, public health and hospital collaborators, the study site coordinators, research nurses and research staff. Conflict of interestJAB none. IR none. MCG none. WRB none. LV received re-search grants from Pfizer and Cubist, consultation fees from Cubist and is involved in sponsored clinical trials with Merck and Sanofi. JDK none. BLC none. AM none. IR was involved in the conception and design of the study, the analysis and interpretation of the data, and writing and revision of the manuscript.

MCG was involved in the acquisition of the data, the analysis and interpretation of the data, and writing and revision of the manuscript. WRB was involved in the design of the study, acquisition of the data and revision of the manuscript. LV was involved in the design of the study, acquisition of the data and revision of the manuscript. OGV was involved in the design of the study, acquisition of the data and revision of the manuscript. JDK was involved in the design of the study, acquisition of the data and revision of the manuscript.

BLC was involved in the design of the study, acquisition of the data and revision of the manuscript. SAM was involved in the design of the study, acquisition of the data and revision of the manuscript. AM was involved in the design of the study, acquisition of the data and revision of the manuscript.

GDS was involved in the conception and design of the study, ac-quisition of the data, the analysis and interpretation of the data, and revision of the manuscript. London: EMA; Contract No. Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. Short and long-term safety of the ASadjuvanted pandemic vaccine. Statement on Seasonal Influenza Vaccine for Canada Communicable Disease Report. Statement on seasonal influenza vaccine for Supplementary statement for the influenza season: update on oculo-respiratory syndrome in association with influenza vaccination.

Novartis suspends distribution of seasonal flu vaccines Agriflu and Fluad in Canada as a precaution. Ottawa: Health Canada;

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jbettinger@nimi.cryptospage.com Phone. () Overview. I am a vaccine safety scientist at the Vaccine Evaluation Center, a leading center for applied. Julie Bettinger (UBC Associate Professor): Epidemiology, Vaccination, Infectious diseases, Health Promotion, Community Health / Public Health, Infectious. world of UBC Library, the second-largest academic research library Scheifele, David W.; Halperin, Scott A.; Bettinger, Julie A.