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Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT06824194 · View on ClinicalTrials.gov ↗
Study Summary
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. 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 until 15 months of age, V06 separated from V05 by 30 days.
Conditions Studied
Interventions
- BIOLOGICAL PCV21 vaccine
- BIOLOGICAL Prevnar 20 vaccine
- BIOLOGICAL M-M-R II vaccine
- BIOLOGICAL Rotarix
- BIOLOGICAL RotaTeq
Study Locations (20)
California
- Helping Hands Healthcare Group - Fullerton- Site Number : 8400063 — Fullerton
- Advanced Investigative Medicine- Site Number : 8400055 — Hawthorne
- Century Research Institute- Site Number : 8400118 — Huntington Park
- Matrix Clinical Research - Huntington Park- Site Number : 8400117 — Huntington Park
- Matrix Clinical Research - Los Angeles- Site Number : 8400026 — Los Angeles
- Matrix Clinical Research - Los Angeles- Site Number : 8400123 — Los Angeles
- Alliance Research Institute - Lynwood- Site Number : 8400099 — Lynwood
- Madera Family Medical Group- Site Number : 8400011 — Madera
- FOMAT-Golden Valley Health Centers- Site Number : 8400084 — Merced
- Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072 — Palo Alto
- Center for Clinical Trials - Paramount- Site Number : 8400100 — Paramount
- Integrated Clinical Research LLC- Site Number : 8400027 — Sherman Oaks
- Emanate Health - Queen of the Valley Hospital- Site Number : 8400105 — West Covina
Alabama
- Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013 — Birmingham
- University of Alabama at Birmingham- Site Number : 8400130 — Birmingham
- Lakeview Clinical Research- Site Number : 8400054 — Guntersville
- Midway Medical Clinic- Site Number : 8400091 — Oneonta
Arkansas
- The Children's Clinic- Site Number : 8400079 — Jonesboro
- Helios CR, Inc. - Little Rock- Site Number : 8400090 — Sherwood
Arizona
- Noble Clinical Research- Site Number : 8400121 — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,320 participants |
| Start Date | 2025-02-18 |
| Est. Completion | 2027-05-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06824194
The ClinicalTrials.gov registry entry for NCT06824194 describes a study currently listed as 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 2,320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 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 Immunization appearing as the primary indexed condition, and to 5 interventions — of which PCV21 vaccine 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: NCT06824194 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arkansas. 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 NCT06824194 about?
NCT06824194 is a clinical study titled "Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age". This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). The stu...
What is the current status of trial NCT06824194?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,320 participants. The study started on 2025-02-18. Estimated completion is 2027-05-12.
What conditions does trial NCT06824194 study?
This clinical trial studies the following conditions: Pneumococcal Immunization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06824194?
The interventions under investigation include: PCV21 vaccine (BIOLOGICAL), Prevnar 20 vaccine (BIOLOGICAL), M-M-R II vaccine (BIOLOGICAL), Rotarix (BIOLOGICAL), RotaTeq (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06824194?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06824194 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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