- Title
- Participant-centered online active surveillance for adverse events following vaccination in a large clinical trial: feasibility and usability study
- Creator
- Munnoch, Sally-Anne; Cashman, Patrick; Peel, Roseanne; Attia, John; Hure, Alexis; Durrheim, David N.
- Relation
- NHMRC.1062536
- Relation
- Journal of Medical Internet Research Vol. 21, Issue 10, no. e14791
- Publisher Link
- http://dx.doi.org/10.2196/14791
- Publisher
- JMIR Publications
- Resource Type
- journal article
- Date
- 2019
- Description
- Background: Active 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. Objective: The 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. Methods: AUSPICE 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. Results: All 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). Conclusions: Vaxtracker 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.
- Subject
- clinical trials; active surveillance; adverse events following immunization; technology; vaccination
- Identifier
- http://hdl.handle.net/1959.13/1455009
- Identifier
- uon:45032
- Identifier
- ISSN:1438-8871
- Rights
- ©Sally-Anne Munnoch, Patrick Cashman, Roseanne Peel, John Attia, Alexis Hure, David N Durrheim. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 23.10.2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
- Language
- eng
- Full Text
- Reviewed
- Hits: 1200
- Visitors: 1321
- Downloads: 126
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | ATTACHMENT02 | Publisher version (open access) | 253 KB | Adobe Acrobat PDF | View Details Download |