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NCT06824194 · ClinicalTrials.gov registry record · Phase 3

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

A Phase 3 study of Pneumococcal Immunization, sponsored by Sanofi.

Recruiting
Registry status
Phase 3
Development phase
2,320
Enrollment target
20
Study locations

NCT06824194 is a Phase 3 study of Pneumococcal Immunization that is actively recruiting participants, run by Sanofi. The registered enrollment target is 2,320 participants, above the 823-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (182% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT06824194, a Phase 3 study of Pneumococcal Immunization, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
Phase 3
Development phase
2,320 participants
Enrollment target
20
Study locations

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

Pneumococcal Immunization

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

FieldValue
Enrollment Target 2,320 participants
Start Date 2025-02-18
Est. Completion 2027-05-12
Phase Phase 3

Sponsor

Sanofi

713 total trials

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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, categorized as Phase 3. The registered enrollment target is 2,320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 823-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (182% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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.

NCT06824194 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arkansas.

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.

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).

Who is sponsoring clinical trial NCT06824194?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.