MedTrace Logo

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

NCT06251024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4541

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infection
  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-03-11
Completion
2025-03-11
FDA Drug
Yes

Countries

  • Australia
  • Chile
  • Colombia
  • Dominican Republic
  • Honduras
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06251024 on ClinicalTrials.gov