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Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

NCT06252285 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6300

Last updated 2026-02-03

No results posted yet for this study

Summary

This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo.

Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.

Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

Conditions

  • RSV Immunisation

Interventions

BIOLOGICAL

RSVt Vaccine

Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

BIOLOGICAL

Placebo

Pharmaceutical form:Suspension of virus in a nasal spray-Route of administration:Intranasal

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2025-12-04
Completion
2025-12-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • China
  • Colombia
  • Finland
  • Japan
  • Kenya
  • Mexico
  • Nepal
  • Puerto Rico
  • South Africa
  • Spain
  • Thailand
  • United Kingdom

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 NCT06252285 on ClinicalTrials.gov