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NCT06838000 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
A Phase 3 study of Pneumococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
- Active
- Registry status
- Phase 3
- Development phase
- 1,268
- Enrollment target
- 20
- Study locations
NCT06838000: Active Phase 3 study of Pneumococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06838000 is a Phase 3 study of Pneumococcal Infections that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,268 participants, above the 778-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (63% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06838000, a Phase 3 study of Pneumococcal Infections, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,268 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).
Primary Outcome
Unsolicited (spontaneously reported) systemic AEs after each and any injection of a pneumococcal vaccine
Conditions Studied
Interventions
- BIOLOGICAL PCV21
- BIOLOGICAL 20vPCV
Study Locations (20)
Florida
- Site # 8400024 - Doral
- Site # 8400007 - Hialeah
- Site # 8400014 - Melbourne
- Site # 8400009 - Miami
- Site # 8400016 - Miami
Harju
- Site # 2330006 - Tallinn
- Site # 2330007 - Tallinn
- Site # 2330002 - Tallinn
Georgia
- Site # 8400021 - Fayetteville
- Site # 8400004 - Union City
Mississippi
- Site # 8400018 - Biloxi
- Site # 8400012 - Ridgeland
New York
- Site #8400010 - Binghamton
- Site # 8400025 - Rochester
Texas
- Site # 8400001 - Houston
- Site # 8400017 - Stephenville
California
- Site # 8400008 - Paramount
Iowa
- Site # 8400003 - Sioux City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,268 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 3 |
What the registry record for NCT06838000 still lists
NCT06838000 is an interventional study that assigns participants to a tested intervention. Its 1,268 participants enrollment target places it among the larger protocols in the corpus, above the 778-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (63% higher).
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 2 interventions - of which PCV21 is the first listed.
NCT06838000 names 20 study sites across 10 states, led by Florida, Harju, Georgia.
Frequently Asked Questions
What is clinical trial NCT06838000 about?
NCT06838000 is a clinical study titled "Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents". The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years o...
What is the current status of trial NCT06838000?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,268 participants. The study started on 2025-02-28. Estimated completion is 2026-12-01.
What conditions does trial NCT06838000 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT06838000?
The interventions under investigation include: PCV21 (BIOLOGICAL), 20vPCV (BIOLOGICAL).
Who is sponsoring clinical trial NCT06838000?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06838000 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pneumococcal Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06838000's enrollment target sits among peer trials
1,268 2nd of 10 the highest of 10 other Pneumococcal Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumococcal Infections 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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