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Clinical trial

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

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Last updated:6th Oct 2021
Status: Recruiting
Identifier: NCT04886596
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

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