Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

NCT06736041 · View on ClinicalTrials.gov ↗

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

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

43 total trials

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 NCT06736041

The ClinicalTrials.gov registry entry for NCT06736041 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 1,714 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 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: NCT06736041 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06736041?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial