NCT06251024

Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4,541 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

Detailed description

Study duration per participant: 6 months. Treatment Duration: 1 IM injection. Participants will be followed for approximately 6 months post- vaccination.

Conditions

• Respiratory Syncytial Virus Infection
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	RSV vaccine candidate	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
BIOLOGICAL	Placebo	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Timeline

• Start date: 2024-04-02
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2024-02-09
• Last updated: 2026-03-10

Locations

25 sites across 6 countries: Australia, Chile, Colombia, Dominican Republic, Honduras, Mexico

Regulatory

• FDA-regulated drug study