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Clinical Trial 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.


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT05964582
Study type Observational
Source Sanofi
Contact
Status Active, not recruiting
Phase
Start date July 11, 2023
Completion date June 28, 2024

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