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NCT05964582 · ClinicalTrials.gov registry record
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers
A clinical trial, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 344
- Enrollment target
NCT05964582: Completed study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05964582 is a clinical trial that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 344 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05964582 has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 344 participants
- Enrollment target
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.
Primary Outcome
To assess RSV A serum Nab titers overall
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2024-07-02 |
What the finished NCT05964582 record still lists
NCT05964582 is an observational study that tracks outcomes without assigning an intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05964582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05964582 about?
NCT05964582 is a clinical study titled "Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers". 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 duri...
What is the current status of trial NCT05964582?
This trial is currently completed. The enrollment target is 344 participants. The study started on 2023-07-11. Estimated completion is 2024-07-02.
Who is sponsoring clinical trial NCT05964582?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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