Observational studyBMJ open2018
Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.
Observational study in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 45 citations in OpenAlex.
- Active Surveillance of Adverse Events Following Influenza Immunization in Jiangsu Province, China: A 2019-2023 Retrospective Study.Vaccines · 2025Article
- The Role of Adverse Event Follow-Up in Advancing the Knowledge of Medicines and Vaccines Safety: A Scoping Review.Drug safety · 2025Article
- Factors influencing adverse events following COVID-19 vaccination.Human vaccines & immunotherapeutics · 2024Article
- Article
- A Web-Based Tool to Report Adverse Drug Reactions by Community Pharmacists in Australia: Usability Testing Study.JMIR formative research · 2023Article
- Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy.JMIR human factors · 2023Article
- Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia.The Lancet regional health. Western Pacific · 2023Article
- Correlation of Postvaccination Fever With Specific Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 BNT162b2 Booster and No Significant Influence of Antipyretic Medication.Open forum infectious diseases · 2022Article
- Vaccine safety: what systems are required to ensure public confidence in vaccines?The Medical journal of Australia · 2022Article
- The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February - August 2021.The Medical journal of Australia · 2022Observational
- Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry.Influenza and other respiratory viruses · 2022Article
- Early solicited adverse events following the BNT162b2 mRNA vaccination, a population survey from Saudi Arabia.Preventive medicine reports · 2021Article
- Enhanced passive safety surveillance of a trivalent and a quadrivalent influenza vaccine in Denmark and Finland during the 2018/2019 season.Human vaccines & immunotherapeutics · 2021Article
- Observational
- Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review.Frontiers in immunology · 2021Review
- 2017/18 and 2018/19 seasonal influenza vaccine safety surveillance, Canadian National Vaccine Safety (CANVAS) Network.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2020Observational
- Comparative Postmarket Safety Profile of Adjuvanted and High-Dose Influenza Vaccines in Individuals 65 Years or Older.JAMA network open · 2020Article
- Timeliness of signal detection for adverse events following influenza vaccination in young children: a simulation case study.BMJ open · 2020Article
- Article
- Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives.Human vaccines & immunotherapeutics · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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
settingObservational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia.
participantsIndividuals 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 measureNear 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.
resultsParticipant 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.
conclusionsNovel, 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.