Full name
A Phase 3b, Open-label Study to Evaluate the Non-inferiority of the Immune Response and to Evaluate the Safety of the RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults ≥60 Years of Age
NCT Number
NCT06389487
Geography
US
Non-US
Locations
Australia, Canada, Germany, Japan, South Africa, United States
Primary Endpoints
- Part A: RSV-A neutralizing titers expressed as group Geometric Mean Titers (GMTs) (RSV-OA over RSV-A-AIR). At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
- Part A: Seroresponse rate (SRR) in RSV-A neutralizing titers. At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
- Part A: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR). At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration
- Part A: SRR in RSV-B neutralizing titers. At 1 month (Day 31) post-RSVPreF3 OA investigational vaccine dose administration compared to baseline (Day 1)
External Link
https://clinicaltrials.gov/study/NCT06389487
Order
1
Disease
Version
Phase
3