Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT05409261
Brief Summary:
Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
Detailed Description:
The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.
200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.
Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants
Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.
Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.
Study:
NCT05409261
Study Brief:
Protocol Section:
NCT05409261