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Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers

NCT04491877 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2025-09-09

Study results available
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Summary

The primary objectives of the study were:

* To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
* To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants.

The secondary objectives of the study were:

* To quantify the amount of vaccine virus shed by each participant by baseline serostatus.
* To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus.
* To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants.
* To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus.
* To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.

Conditions

  • Respiratory Syncytial Virus Infection

Interventions

BIOLOGICAL

RSV vaccine formulation 1

Pharmaceutical form: Suspension of virus Route of administration: Intranasal

BIOLOGICAL

RSV vaccine formulation 2

Pharmaceutical form: Suspension of virus Route of administration: Intranasal

BIOLOGICAL

Placebo

Pharmaceutical form: Suspension Route of administration: Intranasal

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2023-04-13
Completion
2023-04-13
FDA Drug
Yes

Countries

  • United States
  • Chile
  • 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 NCT04491877 on ClinicalTrials.gov