MedTrace Logo

Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

NCT05964582 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 344

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences &amp; Operations · Sanofi

Eligibility

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

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2024-07-02
Completion
2024-07-02

Countries

  • United States
  • Finland
  • Ghana
  • Honduras
  • India
  • Spain
  • Thailand

Study Locations

More Related Trials

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 NCT05964582 on ClinicalTrials.gov