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Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.

ABSTRACT: OBJECTIVE:To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety. DESIGN AND SETTING:Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia. PARTICIPANTS:Individuals aged ?6 months who received a routine seasonal influenza vaccine at a participating site (n=102?911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73?892; 71.8%). MAIN OUTCOME MEASURE:Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt. RESULTS:Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42?869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ?65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels. CONCLUSIONS:Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.

SUBMITTER: Pillsbury AJ

PROVIDER: S-EPMC6196842 | biostudies-other | 2018 Oct

REPOSITORIES: biostudies-other

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Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.

Pillsbury Alexis J AJ Glover Catherine C Jacoby Peter P Quinn Helen E HE Fathima Parveen P Cashman Patrick P Leeb Alan A Blyth Christopher C CC Gold Michael S MS Snelling Thomas T Macartney Kristine K KK

BMJ open 20181018 10

<h4>Objective</h4>To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety.<h4>Design and setting</h4>Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia.<h4>Participants</h4>Individuals aged ≥6 months who received a routin ...[more]

PMID: 30341132

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Project description:BackgroundThe effectiveness of currently licensed vaccines against influenza has not been clearly established, especially among individuals at increased risk for complications from influenza. We used a test-negative approach to estimate influenza vaccine effectiveness (IVE) against hospitalization with laboratory-confirmed influenza based on data collected from the Global Influenza Hospital Surveillance Network (GIHSN).Methods and findingsThis was a multi-center, prospective, active surveillance, hospital-based epidemiological study during the 2012-2013 influenza season. Data were collected from hospitals participating in the GIHSN, including five in Spain, five in France, and four in the Russian Federation. Influenza was confirmed by reverse transcription-polymerase chain reaction. IVE against hospitalization for laboratory-confirmed influenza was estimated for adult patients targeted for vaccination and who were swabbed within 7 days of symptom onset. The overall adjusted IVE was 33% (95% confidence interval [CI], 11% to 49%). Point estimates of IVE were 23% (95% CI, -26% to 53%) for influenza A(H1N1)pdm09, 30% (95% CI, -37% to 64%) for influenza A(H3N2), and 43% (95% CI, 17% to 60%) for influenza B/Yamagata. IVE estimates were similar in subjects <65 and ≥65 years of age (35% [95% CI, -15% to 63%] vs.31% [95% CI, 4% to 51%]). Heterogeneity in site-specific IVE estimates was high (I2 = 63.4%) for A(H1N1)pdm09 in patients ≥65 years of age. IVE estimates for influenza B/Yamagata were homogenous (I2 = 0.0%).ConclusionsThese results, which were based on data collected from the GIHSN during the 2012-2013 influenza season, showed that influenza vaccines provided low to moderate protection against hospital admission with laboratory-confirmed influenza in adults targeted for influenza vaccination. In this population, IVE estimates against A(H1N1)pdm09 were sensitive to age group and study site. Influenza vaccination was moderately effective in preventing admissions with influenza B/Yamagata for all sites and age groups.

Project description:BackgroundThe Global Influenza Hospital Surveillance Network (GIHSN) aims to determine the burden of severe influenza disease and Influenza Vaccine Effectiveness (IVE). This is a prospective, active surveillance and hospital-based epidemiological study to collect epidemiological data in the GIHSN. In the 2016-2017 influenza season, 15 sites in 14 countries participated in the GIHSN, although the analyses could not be performed in 2 sites. A common core protocol was used in order to make results comparable. Here we present the results of the GIHSN 2016-2017 influenza season.MethodsA RT-PCR test was performed to all patients that accomplished the requirements detailed on a common core protocol. Patients admitted were included in the study after signing the informed consent, if they were residents, not institutionalised, not discharged in the previous 30 days from other hospitalisation with symptoms onset within the 7 days prior to admission. Patients 5 years old or more must also complied the Influenza-Like Illness definition. A test negative-design was implemented to perform IVE analysis. IVE was estimated using a logistic regression model, with the formula IVE = (1-aOR) × 100, where aOR is the adjusted Odds Ratio comparing cases and controls.ResultsAmong 21,967 screened patients, 10,140 (46.16%) were included, as they accomplished the inclusion criteria, and tested, and therefore 11,827 (53.84%) patients were excluded. Around 60% of all patients included with laboratory results were recruited at 3 sites. The predominant strain was A(H3N2), detected in 63.6% of the cases (1840 patients), followed by B/Victoria, in 21.3% of the cases (618 patients). There were 2895 influenza positive patients (28.6% of the included patients). A(H1N1)pdm09 strain was mainly found in Mexico. IVE could only be performed in 6 sites separately. Overall IVE was 27.24 (95% CI 15.62-37.27. Vaccination seemed to confer better protection against influenza B and in people 2-4 years, or 85 years old or older. The aOR for hospitalized and testing positive for influenza was 3.02 (95% CI 1.59-5.76) comparing pregnant with non-pregnant women.ConclusionsVaccination prevented around 1 in 4 hospitalisations with influenza. Sparse numbers didn't allow estimating IVE in all sites separately. Pregnancy was found a risk factor for influenza, having 3 times more risk of being admitted with influenza for pregnant women.

Dataset Information

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.

Publications

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.

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