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Clinical trial

A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

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Last updated:16th Nov 2021
Status: Recruiting
Identifier: NCT05059301
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

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