Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
NCT ID:
NCT04798027
Pre Assignment Details:
Participants (aged 18-49 years) in Sentinel Cohort received two vaccinations, 21 days apart. FEC participants were stratified into 2 age groups: younger adult group (18-49 years) and the older adult group (greater than or equal to \[\>=\] 50 years). FEC Cohort 1 participants received a single injection of study vaccine or placebo, while participants in Cohort 2 received two vaccinations (21 days apart). A total of 182 participants were enrolled, of which 180 were vaccinated in the study.
Recruitment Details:
The study was conducted at 17 active sites in 4 countries between 12 Mar 2021 and 27 Jun 2022. Study consisted of 2 cohorts: Sentinel Cohort and Full Enrollment Cohort (FEC). For analysis purpose, Baseline, safety and outcome measure data was planned to be collected, analyzed and reported for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
Study:
NCT04798027
Study Brief:
Results Section:
NCT04798027