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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT07002060
Brief Summary:
The purpose of this study is to assess the safety of vYF (investigational vaccine) compared to the safety of YF-VAX (YF licensed vaccine) in adults aged 18 years up to 60 years.
Study details include:
* The study duration will be up to approximately 6 months.
* One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit.
* The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6.
Number of Participants:
A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX):
Group 1: vYF; N=480 Group 2: YF-VAX; N=160
Study Arms and Duration:
Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.
Study:
NCT07002060
Study Brief:
Protocol Section:
NCT07002060