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NCT07348692 · ClinicalTrials.gov registry record · Phase 3
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
A Phase 3 study, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,195
- Enrollment target
NCT07348692 is a Phase 3 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 2,195 participants.
The verdict
NCT07348692, a Phase 3 study, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,195 participants
- Enrollment target
Study Summary
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
Interventions
- BIOLOGICAL PCV21 vaccine
- BIOLOGICAL 20vPCV licensed vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,195 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2028-05-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07348692
The ClinicalTrials.gov registry entry for NCT07348692 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 2,195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PCV21 vaccine is the first listed.
NCT07348692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07348692 about?
NCT07348692 is a clinical study titled "Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age". This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are give...
What is the current status of trial NCT07348692?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,195 participants. The study started on 2026-01-20. Estimated completion is 2028-05-29.
What interventions are being tested in trial NCT07348692?
The interventions under investigation include: PCV21 vaccine (BIOLOGICAL), 20vPCV licensed vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT07348692?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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