Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 1720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open-label study. Both investigator and participant know the identity of the intervention assigned.
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Open-label, Multi-country Study to Evaluate the Immunogenicity, Safety, Reactogenicity and Persistence of a Single Dose of the RSVPreF3 OA Investigational Vaccine and Different Revaccination Schedules in Adults Aged 60 Years and Above
Actual Study Start Date: February 15, 2021
Estimated Primary Completion Date: May 24, 2022
Estimated Study Completion Date: May 24, 2024
Arm:
- Experimental: Group A
- Experimental: Group B
- Experimental: Group C
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 1720 |
| Actual Study start date | 15 February 2021 |
| Estimated Study Completion Date | 24 May 2024 |