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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06397768
The ClinicalTrials.gov registry entry for NCT06397768 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2,226 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 5 interventions - of which Hepatitis B vaccine is the first listed.
NCT06397768 reports 0 study locations.
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.
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