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NCT06824181 · ClinicalTrials.gov registry record · Phase 3

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

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

Active
Registry status
Phase 3
Development phase
580
Enrollment target
20
Study locations

NCT06824181 is a Phase 3 study of Pneumococcal Immunization that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 580 participants, below the 1,403-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT06824181, a Phase 3 study of Pneumococcal Immunization, is active but no longer recruiting, sponsored by Sanofi.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
580 participants
Enrollment target
20
Study locations

Study Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series 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 (MoA). 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)

Texas

  • Helios Clinical Research - BUR PEDI- Site Number : 8400016 - Burleson
  • Clinsearch Inc at VAST Clinical Research- Site Number : 8400028 - Euless
  • DM Clinical Research - Houston - Jones Road- Site Number : 8400012 - Houston
  • University of Texas Medical Branch at Galveston- Site Number : 8400005 - League City
  • Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024 - Stephenville

Florida

  • The Medici Medical Research- Site Number : 8400008 - Hollywood
  • Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027 - Miami
  • Atlantis Clinical Research- Site Number : 8400009 - Miami

New York

  • Finger Lakes Medical Research - Cortland- Site Number : 8400022 - Cortland
  • University of Rochester Medical Center- Site Number : 8400019 - Rochester
  • SUNY Upstate Medical University - Syracuse- Site Number : 8400015 - Syracuse

Reg Metropolitana de Santiago

  • Investigational Site Number : 1520003 - Santiago
  • Investigational Site Number : 1520002 - Santiago
  • Investigational Site Number : 1520001 - Santiago

California

  • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025 - Los Angeles

Iowa

  • Velocity Clinical Research - Sioux City- Site Number : 8400007 - Sioux City

Kentucky

  • Private Practice - Dr. Michael W. Simon- Site Number : 8400001 - Lexington

Louisiana

  • Velocity Clinical Research - New Orleans- Site Number : 8400006 - New Orleans

Trial Details

FieldValue
Enrollment Target 580 participants
Start Date 2025-02-27
Est. Completion 2027-09-10
Phase Phase 3

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06824181

The ClinicalTrials.gov registry entry for NCT06824181 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,403-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (59% lower). 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.

NCT06824181 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Texas, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT06824181 about?

NCT06824181 is a clinical study titled "Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-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 measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 dose...

What is the current status of trial NCT06824181?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2025-02-27. Estimated completion is 2027-09-10.

What conditions does trial NCT06824181 study?

This clinical trial studies the following conditions: Pneumococcal Immunization.

What interventions are being tested in trial NCT06824181?

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 NCT06824181?

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

Where is trial NCT06824181 being conducted?

This trial has 20 study locations across California, Florida, Iowa, Kentucky, Louisiana. 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.