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ACTIVE NOT RECRUITING 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

NCT06824181 · View on ClinicalTrials.gov ↗

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

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

275 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. 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 580 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: NCT06824181 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Texas, Florida, New York. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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

Who is sponsoring clinical trial NCT06824181?

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 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.

Related

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