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

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.

Timeline

Start

2024-11-25

Primary completion

2025-06-11

Completion

2025-06-11

Drugs

Indications