UID:
almafu_9961627102002883
Format:
1 online resource (56 pages)
Edition:
1st ed.
ISBN:
9789240027398
Content:
This WHO document serves as a protocol template for Cohort Event Monitoring (CEM) studies aimed at detecting safety signals following COVID-19 vaccination. It is designed to guide researchers in implementing active safety surveillance using harmonized tools and methods. The protocol facilitates the collection and analysis of adverse events of special interest (AESI) as part of the broader COVID-19 vaccine safety surveillance. Developed with input from global experts and leveraging previous experiences with CEM in the H1N1 influenza pandemic, this template is adaptable for use in various country-specific contexts. It is intended for researchers and public health professionals conducting observational studies on vaccine safety.
Note:
Intro -- Fig 1: Probability of observing at least one event assuming a given event probability, by varying sample sizes up to 60,000. The horizontal dotted lined correspond to a 95% probability of observing at least one event. -- Fig 2: Data collection and timing (a) for all study participants, and (b) additional data collection for participants in the reactogenicity subset -- illustrated for two doses of COVID‑19 vaccines 28 days apart (timing between doses may differ) -- Table 1: Study sites with principal investigators and contact details -- Table 2: Sample size required to rule out events with the indicated frequency if no event is observed with 95% confidence -- Table 3: Sample size needed to rule out a relative risk if no event is observed within the risk window with 95% confidence. -- Table 4: Sample size needed to rule out different levels of relative risk if no event is observed within the risk window with 95% confidence. Additional results correspond to different values of background rates. -- Table 5: Sample size required to estimate reactogenicity prevalence with the indicated level of precision with 95% confidence interval using Clopper-Pearson exact calculation for the proportion. -- 1. Contents -- 2. List of tables -- 3. List of figures -- 4. Protocol sign-off -- 5. Documentation of protocol amendments -- 6. Study team and responsibilities -- 6.1 Study team -- 6.2 Responsibilities -- 7. Abbreviations -- 8. Synopsis -- 9. Background and rationale -- 10. Objectives -- 11. Methods -- 11.1 Study design -- 11.2 Study population -- 11.2.1 Inclusion criteria -- 11.2.2 Exclusion criteria -- 11.2.3 Withdrawal from the study -- 11.3 Study sites -- 11.4 Study period -- 11.4.1 Start of study and duration of follow-up -- 11.4.2 Study completion and end of study -- 11.5 Sample sizes -- 11.5.1 Sample size for overall cohort.
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11.5.2 Sample size for reactogenicity subset -- 11.6 Study variables -- 11.6.1 Exposure of interest -- 11.6.2 Study outcomes -- 11.6.2.1 Serious adverse events -- 11.6.2.2 Adverse events of special interest resulting in hospitalization -- 11.6.2.3 Reactogenicity -- 11.6.2.4 Severe COVID‑19 disease -- 11.7 Study flow: data sources and data collection -- 11.7.1 Vaccination and enrolment -- 11.7.2 Vaccination during the follow-up period -- 11.7.3 Follow-up -- 11.7.4 Identification of AESIs and SAEs -- 11.7.5 Pregnancy -- 11.7.6 Data collection at withdrawal/lost to follow-up -- 11.8 Data analysis -- 11.8.1 Descriptive analysis of demographics and baseline characteristics -- 11.8.2 Statistical analyses -- 12. Data management -- 12.1 Data security -- 12.2 Data transfer -- 12.3 Source documents -- 12.4 Data retention and archiving -- 13. Quality assurance, monitoring and reporting -- 13.1 Monitoring -- 13.2 Interim analyses and reporting -- 13.3 Final analyses and reporting -- 14. Study management -- 14.1 National pharmacovigilance centre/AEFI committee/national immunization programme manager/dedicated scientific committee -- 14.2 Changes to the protocol -- 14.3 Management and reporting of adverse events/adverse reactions -- 15. Ethical considerations -- 15.1 Guiding principles -- 15.2 Respecting participants' autonomy -- 15.3 Participant confidentiality -- 15.4 Independent ethics committee/institutional review board -- 16. Limitations -- 17. References -- 18. Appendices -- Appendix 1 -- Data dictionary -- Appendix 2 -- Adverse events of special interest -- Appendix 3 -- Relationships between study tables -- Appendix 4 -- Adult informed consent form -- Participant information sheet.
Additional Edition:
Print version: Protocol Template to Be Used As Template for Observational Study Protocols for Cohort Event Monitoring (CEM) for Safety Signal Detection after Vaccination with COVID-19 Vaccines Geneva : World Health Organization,c2021
Language:
English
Keywords:
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URL:
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