NCT05964582

Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

A Multi-center, Multi-national, Prospective Surveillance Study of Respiratory Syncytial Virus Disease in Infants and Toddlers 6 to < 22 Months of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 21 Months
• Healthy volunteers: Accepted

Summary

The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to \< 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.

Detailed description

The duration of the study will be 6 months for each participant.

Conditions

• Respiratory Syncytial Virus Infections

Timeline

• Start date: 2023-07-11
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2023-07-28
• Last updated: 2024-09-19

Locations

15 sites across 7 countries: United States, Finland, Ghana, Honduras, India, Spain, Thailand