Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04491877 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 259 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (332% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded
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 |
What the finished NCT04491877 record still lists
NCT04491877 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (332% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04491877 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04491877's enrollment target sits among peer trials
259 167th of 2000 higher than 1,834 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02361320 · 259 participants · NA
Computed Tomography in Diagnosing Patients With Pancreatic or Hepatobiliary Cancer
- NCT06797258 · 259 participants · NA
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
- NCT06990425 · 259 participants · NA
CLOSM Trial: Groin Closure Using Layered Option for Suture Material
- NCT07399977 · 259 participants · NA
Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI