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NCT06397768 · ClinicalTrials.gov registry record · Phase 3
Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,226
- Enrollment target
NCT06397768: Clinical Trial Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06397768 is a Phase 3 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,226 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06397768, a Phase 3 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,226 participants
- Enrollment target
Study Summary
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Primary Outcome
Antibody titers at Day 85
Interventions
- BIOLOGICAL Hepatitis B vaccine
- BIOLOGICAL RSVt vaccine
- BIOLOGICAL Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine
- BIOLOGICAL Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine
- BIOLOGICAL Streptococcus pneumoniae vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,226 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2025-09-18 |
| Phase | Phase 3 |
Why NCT06397768 stopped before completion
NCT06397768 is an interventional study that assigns participants to a tested intervention. Its 2,226 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 5 interventions - of which Hepatitis B vaccine is the first listed.
NCT06397768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06397768 about?
NCT06397768 is a clinical study titled "Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers". This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to ...
What is the current status of trial NCT06397768?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,226 participants. The study started on 2024-05-13. Estimated completion is 2025-09-18.
What interventions are being tested in trial NCT06397768?
The interventions under investigation include: Hepatitis B vaccine (BIOLOGICAL), RSVt vaccine (BIOLOGICAL), Diphtheria, tetanus, pertussis, poliomyelitis , Haemophilus influenzae type b, and hepatitis B vaccine (BIOLOGICAL), Diphtheria, tetanus, pertussis, Haemophilus influenzae type b and poliomyelitis vaccine (BIOLOGICAL), Streptococcus pneumoniae vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06397768?
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 NCT06397768's enrollment target sits among peer trials
2,226 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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