Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT06838000 · View on ClinicalTrials.gov ↗
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).
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06838000
The ClinicalTrials.gov registry entry for NCT06838000 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,268 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 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06838000 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Harju, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06838000?
The interventions under investigation include: PCV21 (BIOLOGICAL), 20vPCV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06838000?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.