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NCT06736041 · ClinicalTrials.gov registry record · Phase 3

Study of a 4-Dose Regimen 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 Pasteur, a Sanofi Company.

Active
Registry status
Phase 3
Development phase
1,714
Enrollment target
20
Study locations

NCT06736041 is a Phase 3 study of Pneumococcal Immunization that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,714 participants, above the 1,025-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (67% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT06736041, a Phase 3 study of Pneumococcal Immunization, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,714 participants
Enrollment target
20
Study locations

Study Summary

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints. 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 RotaTeq
  • BIOLOGICAL Vaxelis vaccine

Study Locations (20)

Florida

  • PAS Research- Site Number : 8400123 - Clearwater
  • Prohealth Research Center- Site Number : 8400159 - Doral
  • NurtureGen Research- Site Number : 8400205 - Homestead
  • EMDA Clinical Research- Site Number : 8400237 - Miami
  • Dade Research Center- Site Number : 8400007 - Miami
  • Acevedo Clinical Research Associates- Site Number : 8400089 - Miami
  • Miami Clinical Research Tower- Site Number : 8400189 - Miami
  • Vasconcello-Cohen MD Research, LLC- Site Number : 8400248 - Miami
  • Bio-Medical Research- Site Number : 8400147 - Miami

California

  • Southland Clinical Research Center- Site Number : 8400243 - Fountain Valley
  • Century Research Institute- Site Number : 8400065 - Huntington Park
  • Matrix Clinical Research - Huntington Park- Site Number : 8400012 - Huntington Park
  • Matrix Clinical Research - Los Angeles- Site Number : 8400013 - Los Angeles
  • University of California Los Angeles Medical Center- Site Number : 8400238 - Los Angeles
  • Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259 - Pasadena
  • FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063 - Ventura

Arizona

  • Sun City Clinical Research- Site Number : 8400247 - Glendale
  • Eclipse Clinical Research- Site Number : 8400029 - Tucson

Arkansas

  • Northwest Arkansas Pediatric Clinic- Site Number : 8400030 - Fayetteville

District of Columbia

  • Velocity Clinical Research - Washington DC- Site Number : 8400049 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,714 participants
Start Date 2024-12-18
Est. Completion 2027-05-17
Phase Phase 3

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06736041

The ClinicalTrials.gov registry entry for NCT06736041 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,714 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,025-participant average among 3 other Pneumococcal Immunization trials with a reported enrollment target (67% higher). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 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.

NCT06736041 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06736041 about?

NCT06736041 is a clinical study titled "Study of a 4-Dose Regimen 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 measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccin...

What is the current status of trial NCT06736041?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,714 participants. The study started on 2024-12-18. Estimated completion is 2027-05-17.

What conditions does trial NCT06736041 study?

This clinical trial studies the following conditions: Pneumococcal Immunization.

What interventions are being tested in trial NCT06736041?

The interventions under investigation include: PCV21 vaccine (BIOLOGICAL), Prevnar 20 vaccine (BIOLOGICAL), M-M-R II vaccine (BIOLOGICAL), RotaTeq (BIOLOGICAL), Vaxelis vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT06736041?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06736041 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. 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.