Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Brief Summary:
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Detailed Description:
The study will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 25000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Actual Study Start Date: May 22, 2021
Estimated Primary Completion Date: May 12, 2022
Estimated Study Completion Date: May 31, 2024
Arm:
- Experimental: RSVPreF3_L1 Group
- Experimental: RSVPreF3_L2 Group
- Experimental: RSVPreF3_L3 Group
- Experimental: RSVPreF3_L4 Group
- Placebo Comparator: Placebo Group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 25000 |
| Actual Study start date | 22 May 2021 |
| Estimated Study Completion Date | 31 May 2024 |