Trial reportJournal of medical Internet research2019
Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability Study.
Trial report in Journal of medical Internet research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.
- Representation of marginalised populations in digital surveillance for notifiable conditions in Australia: a systematic review.Perspectives in public health · 2024Pooled it
- Prevention of Adverse Cardiovascular Events Using the 23-Valent Pneumococcal Polysaccharide Vaccine: A Randomized Clinical Trial.JAMA cardiology · 2025Trial
- Impact of recruitment strategies on individual participation practices in the Canadian National Vaccine Safety Network: prospective cohort study.Frontiers in public health · 2024Article
- Article
- A Preliminary Investigation on a Commercial Ovine Pasteurellosis Vaccine Using Clinical and Pathological Endpoints.Infection and drug resistance · 2022Article
- Observational
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundActive participant monitoring of adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety postmarketing. Vaxtracker, an online tool used to monitor vaccine safety, has successfully demonstrated its usefulness in postmarketing surveillance of newly introduced childhood vaccines. However, its use in older participants, or for monitoring patients participating in large clinical trials, has not been evaluated.
objectiveThe objective of this study was to monitor AEFIs in older participants enrolled in the Australian Study for the Prevention through the Immunisation of Cardiovascular Events (AUSPICE) trial, and to evaluate the usefulness and effectiveness of Vaxtracker in this research setting.
methodsAUSPICE is a multicenter, randomized, placebo-controlled, double-blinded trial in which participants aged 55 to 61 years were given either the pneumococcal polysaccharide vaccine (23vPPV) or 0.9% saline placebo. Vaxtracker was used to monitor AEFIs in participants in either treatment arm through the administration of two online questionnaires. A link to each questionnaire was sent to participants via email or short message service (SMS) text message 7 and 28 days following vaccination. Data were collated and analyzed in near-real time to identify any possible safety signals indicating problems with the vaccine or placebo.
resultsAll 4725 AUSPICE participants were enrolled in Vaxtracker. Participant response rates for the first and final survey were 96.47% (n=4558) and 96.65% (n=4525), respectively. The online survey was completed by 90.23% (4083/4525) of Vaxtracker participants within 3 days of receiving the link. AEFIs were reported by 34.40% (805/2340) of 23vPPV recipients and 10.29% (240/2332) of placebo recipients in the 7 days following vaccination. Dominant symptoms for vaccine and placebo recipients were pain at the injection site (587/2340, 25.09%) and fatigue (103/2332, 4.42%), respectively. Females were more likely to report symptoms following vaccination with 23vPPV compared with males (433/1138, 38.05% versus 372/1202, 30.95%; P<.001).
conclusionsVaxtracker is an effective tool for monitoring AEFIs in the 55 to 61 years age group. Participant response rates were high for both surveys, in both treatment arms and for each method of sending the survey. This study indicates that administration of 23vPPV was well-tolerated in this cohort. Vaxtracker has successfully demonstrated its application in the monitoring of adverse events in near-real time following vaccination in people participating in a national clinical trial.
trial registrationAustralian New Zealand Trial Registry Number (ACTRN) 12615000536561; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368506.
Indexed as
Identifiers
What OpenQuestion holds
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.