NCT06705140View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

947

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

April 17, 2026

Study Completion Date

April 17, 2026

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

Trial Locations (4)

10205

Investigational Site Number : 2140002, Santo Domingo

11101

Investigational Site Number : 3400001, Tegucigalpa

Investigational Site Number : 3400003, Tegucigalpa

21104

Investigational Site Number : 3400002, San Pedro Sula

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY