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NCT04491877 · ClinicalTrials.gov registry record · Phase 1
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 259
- Enrollment target
NCT04491877 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 259 participants.
The verdict
NCT04491877, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 259 participants
- Enrollment target
Study Summary
The primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: * To quantify the amount of vaccine virus shed by each participant by baseline serostatus. * To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. * To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. * To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. * To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSV vaccine formulation 1
- BIOLOGICAL RSV vaccine formulation 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2023-04-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04491877
The ClinicalTrials.gov registry entry for NCT04491877 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04491877 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04491877 about?
NCT04491877 is a clinical study titled "Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers". The primary objectives of the study were: * To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. * To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses...
What is the current status of trial NCT04491877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 259 participants. The study started on 2020-09-17. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT04491877?
The interventions under investigation include: Placebo (BIOLOGICAL), RSV vaccine formulation 1 (BIOLOGICAL), RSV vaccine formulation 2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04491877?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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