Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents
Active, not recruiting · Phase 3 · NCT06838000
Conditions: Pneumococcal Infections
At a glance
- Research payments reported, 2025
- $2.1M
- U.S. investigators named
- 22
- Sites paid
- 19
- Planned or actual enrollment
- 1,268
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- PCV21 (biological), 20vPCV (biological)
- Dates
- Started 2025-02-28; completion 2026-12-01
- Results posted
- Not yet
The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).
From ClinicalTrials.gov, last updated 2025-10-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $2.1M in research payments for this study in 2025 (370 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
- Swetha Geetha Pinninti, M.D Pediatric Infectious Disease · Birmingham, AL
- Tequilla L. Pryor, M.D. Pediatrics · Fpo, AP
- Carey Chronis, M.D. Pediatrics · Ventura, CA
- Liberation B. De Leon, M.D. Pediatrics · Paramount, CA
- Jeffrey Kaplan, MD Pediatrics · Santa Maria, CA
- Giselle Deiros, MD Pediatrics · Miami, FL
- Isaac C. Luzardo, M.D. Pediatrics · Miami, FL
- Mario A. Reyes, M.D. Pediatrics · Miami, FL
- Georges N. Saliba, M.D. P.A. Pediatrics · Miami, FL
- Dwight D. Blake, MD Internal Medicine · Union City, GA
- Nicholas C. Bechtold, D.O. Family Medicine · Sioux City, IA
- Matthew D. Wenker, MD Internal Medicine · Erlanger, KY
- Bob Hutchins Internal Medicine · Jackson, MS
- Paul G. Matherne, MD Family Medicine · Gulfport, MS
- Ariana A. Bauer, M.D. Internal Medicine · Omaha, NE
- Frank Eder, MD Family Medicine · Binghamton, NY
- Eric J. Lorraine, DO Family Medicine · Endwell, NY
- Jennifer Nayak, MD Pediatric Infectious Disease · Rochester, NY
- Wayne Shreffler, M.D. Pediatrics · New York, NY
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- Benjamin A. Marcum, M.D. Family Medicine · Stephenville, TX
- Wilson C. Cueva, M.D. Neurology · Green Bay, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Acevedo Clinical Research Associates Co $445,304
- Neostart Corporation Dba Aga Clinical Trials $362,073
- Javara Inc $297,059
- Velocity Clinical Research,inc $242,317
- Dynamed Clinical Research,lp $154,193
- Oakland Hills Dermatology PC $124,763
- Strong Memorial Hospital, NY $97,579
- Prohealth Research Center $84,742
- Sky Clinical Research Network Group Integrative Skin Care of Ms Skycrng $64,184
- Hope Research Network Trials Llc $58,247
- Fomat Medical Research Inc $45,000
- Massachusetts General Hospital, MA $40,000
- $29,107
- University of Alabama Hospital, AL $22,708
- Center for Clinical Trials Llc $22,276
- Prohealth Research Center Inc $16,866
- Center for Clinical Trials,llc $15,850
- Quality Clinical Research Inc $10,677
- Quality Clinical Research $8,629
- Velocity Clinical Research $497
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.