A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study is double blind from start to final analysis after which the study is considered single blind.
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind, Multi-country Study to Evaluate Consistency, Safety, and Reactogenicity of 3 Lots of RSVPreF3 OA Investigational Vaccine Administrated as a Single Dose in Adults Aged 60 Years and Above
Actual Study Start Date: October 1, 2021
Estimated Primary Completion Date: February 1, 2022
Estimated Study Completion Date: July 4, 2022
Arm:
- Experimental: RSVPreF3_Grp1 Group
- Experimental: RSVPreF3_Grp2 Group
- Experimental: RSVPreF3_Grp3 Group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 750 |
| Actual Study start date | 01 October 2021 |
| Estimated Study Completion Date | 04 July 2022 |