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A Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

NCT06705140 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 947

Last updated 2026-02-03

No results posted yet for this study

Summary

This study is a Phase III, parallel group, randomized, observer blind, placebo controlled, multi-national, multi-center, multi-arm study to be conducted in 947 healthy children enrolled at 6 months to \<22 months of age. The purpose of the study is to evaluate the non-inferiority of the immune response of the lower dose (LD) when compared to the standard dose (SD) respiratory syncytial virus infant and toddler (RSVt) vaccine and the safety of the LD, SD and high dose (HD) vaccine in preterm born children and of the HD vaccine in full term born children administered by intranasal route and compared to placebo.

Conditions

  • RSV Immunisation

Interventions

BIOLOGICAL

Low Dose (LD) RSVt vaccine

Pharmaceutical form: Liquid for nasal spray Route of administration: Intranasal

BIOLOGICAL

Standard Dose (SD) RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

BIOLOGICAL

High Dose (HD) RSVt vaccine

Pharmaceutical form:Liquid for nasal spray-Route of administration:Intranasal

BIOLOGICAL

Placebo

Pharmaceutical form:Liquid for 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
2024-11-25
Primary Completion
2025-06-11
Completion
2025-06-11
FDA Drug
Yes

Countries

  • Dominican Republic
  • Honduras

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 NCT06705140 on ClinicalTrials.gov