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
Active, not recruiting · Phase 3 · NCT06824181
Conditions: Pneumococcal Immunization
At a glance
- Research payments reported, 2025
- $445,643
- U.S. investigators named
- 13
- Sites paid
- 13
- Planned or actual enrollment
- 580
About the trial
- Sponsor
- Sanofi
- Tested
- PCV21 vaccine (biological), Prevnar 20 vaccine (biological), M-M-R II vaccine (biological), Rotarix (biological), RotaTeq (biological), Vaxelis vaccine (biological), Varivax (biological), Priorix (biological), VAQTA (biological), Havrix (biological)
- Dates
- Started 2025-02-27; completion 2027-09-10
- Results posted
- Not yet
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 pedia…
From ClinicalTrials.gov, last updated 2026-02-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $445,643 in research payments for this study in 2025 (115 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- William Towner, MD Internal Medicine · Los Angeles, CA
- Leyvi Alvarado Miranda, MD Family Medicine · Miami, FL
- Livasky Concepcion Perez, M.D. Internal Medicine · Aventura, FL
- Timothy W. Ryschon, MD Emergency Medicine · Pensacola Beach, FL
- Michael W. Simon, M.D. Pediatrics · Nicholasville, KY
- Joseph B. Domachowske, MD Pediatric Infectious Disease · Syracuse, NY
- Michael Quinn, MD, PHD Pediatric Infectious Disease · Rochester, NY
- Christopher A. Smith, M.D. Allergy & Immunology · Horseheads, NY
- Cheryl Duffy Pediatrics · Hermitage, PA
- Robert A. Clifford, M.D. Pediatrics · Charleston, SC
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- Tiffany Baird, M.D. Pediatrics · Eastland, TX
- Richard E. Rupp, MD Adolescent Medicine · Galveston, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Research Found of State University of New York $135,551
- Square 1 Clinical Research Inc $72,374
- University of Texas Medical Branch Galveston, TX $65,412
- Strong Memorial Hospital, NY $47,349
- Dynamed Clinical Research,lp $31,739
- West Los Angeles Medical Center $31,265
- The Medici Medical Research Llc $14,000
- Michael W Simon,md,psc $11,585
- Finger Lakes Medical Research, PLLC $10,960
- Helios Cr, Inc $9,631
- $7,731
- Clinical Research of California, Llc $4,000
- Coastal Pediatric Research $2,299
- Atlantis Clinical Research Llc $1,748
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.