Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Active, not recruiting · Phase 3 · NCT06736041
Conditions: Pneumococcal Immunization
At a glance
- Research payments reported, 2025
- $2.7M
- U.S. investigators named
- 53
- Sites paid
- 51
- Planned or actual enrollment
- 1,714
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- PCV21 vaccine (biological), Prevnar 20 vaccine (biological), M-M-R II vaccine (biological), RotaTeq (biological), Vaxelis vaccine (biological), Varivax (biological), Hexaxim Vaccine (biological)
- Dates
- Started 2024-12-18; completion 2027-05-17
- Results posted
- Not yet
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. Rout…
From ClinicalTrials.gov, last updated 2026-04-22. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $2.7M in research payments for this study in 2025 (324 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
- Virginia L. Thomas, M.D. Pediatrics · Fayetteville, AR
- Peyman Banooni, M.D. OB-GYN (Obstetrics & Gynecology) · Beverly Hills, CA
- Carey Chronis, M.D. Pediatrics · Ventura, CA
- Jose M. Diaz, M.D Pediatrics · Downey, CA
- Albert A. Nassir, M.D OB-GYN (Obstetrics & Gynecology) · Los Angeles, CA
- Tzu-jen Tzao, M.D. Emergency Medicine · Los Angeles, CA
- Giselle Deiros, MD Pediatrics · Miami, FL
- Ramon A. Guevara, DO Family Medicine · Key Biscayne, FL
- David A. Hensley, MD Pediatrics · Pace, FL
- Teena L. Hughes, M.D. Pediatrics · Tampa, FL
- Michele A. Johnson-towson, MD Pediatrics · Tampa, FL
- Karen A. Kelly, MD Pediatrics · Clearwater, FL
- Carlos Perez, M.D. Family Medicine · Coral Gables, FL
- Angel E. Rico, MD General Practice · Miami Lakes, FL
- Elvira J. Rives, MD Pediatrics · Miami Lakes, FL
- Lilia Roque-guerrero, MD Pediatrics · Miami, FL
- Georges N. Saliba, M.D. P.A. Pediatrics · Miami, FL
- Isaac Talmaciu, M.D. Pediatric Pulmonology · Pembroke Pines, FL
- Martha I. Buitrago, MD Infectious Disease · Idaho Falls, ID
- Glenn R. Leavitt, DO OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Joseph R. Moore, M.D. Pediatrics · Ammon, ID
- Gary M. Ullery, D.O. Internal Medicine · Blackfoot, ID
- Ellen A. Losew, MD Pediatrics · Hutchinson, KS
- Michael A. Rausch, M.D. Family Medicine · Augusta, KS
- Randall L. Schumacher, MD Pediatrics · Topeka, KS
- Nouh Mazloum, DO Emergency Medicine · Wayne, MI
- Amruta N. Padhye, M.D. Pediatric Infectious Disease · Columbia, MO
- Awawu E. Igbinadolor, M.D. Adolescent Medicine · Monroe, NC
- Cornell V. Calinescu, MD Emergency Medicine · Las Vegas, NV
- Anne M. Zomcik, MD Pediatrics · Erie, PA
- Carmen Colon-tarbal, M.D. Pediatrics · San Juan, PR
- Elba A. Perez, M.D. General Practice · Trujillo Alto, PR
- Jeffrey Quinones, MD, MBA Pediatrics · Guayama, PR
- Jose L. Torres-silva, MD Pediatrics · Coto Laurel, PR
- Fernando J. Ysern Borras, M.D. Pediatrics · Caguas, PR
- Scott Dobson, M.D. Pediatrics · Simpsonville, SC
- Catherine R. Kramp, MD Pediatrics · Summerville, SC
- Haider Afzal, MD Family Medicine · Baytown, TX
- Ronald M. Blair, M.D. P.A. Pediatrics · Dallas, TX
- Michael E. Bornstein, MD Pediatrics · Richmond, TX
- Waymon Drummond, M.D. Internal Medicine · Dallas, TX
- Wieslaw J. Jakubowski, M.D. Pediatrics · Corpus Christi, TX
- Taryll L. Jenkins, M.D. OB-GYN (Obstetrics & Gynecology) · Katy, TX
- Mark Koch, M.D. Family Medicine · Fort Worth, TX
- Ayesha Mian, MD Internal Medicine · Katy, TX
- Frederick Ogwara, MD Pediatrics · Rosharon, TX
- Ifeyinwa P. Onwudiwe, MD Pediatrics · Pearland, TX
- Naila F. Siddiqi, MD Pediatrics · Houston, TX
- Stephen J. Bruce, MD Family Medicine · Ogden, UT
- Nathan G. Forbush, M.D. Pediatrics · Layton, UT
- Jake C. Jones, M.D. Pediatrics · Murray, UT
- Richard L. Bennett JR., MD Pediatrics · Richmond, VA
- Sofia Teferi, MD Pediatrics · Richmond, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Matrix Clinical Research,inc $370,732
- Bmh,inc $237,861
- Clinical Research Puerto Rico,inc $189,100
- Caribbean Medical Research Center Llc $140,149
- Neutra Life Sciences Llc $116,825
- Elba Antoinette Peres Vargas $116,185
- Ponce School of Medicine Foundation, Inc $115,918
- Community Clinical Research Network Inc $112,539
- Medical Associates of Northwest Arkansas,pa $77,975
- Physicians Administrative Solutions Llc $76,787
- Chemidox Clinical Trials $76,140
- Linq Research Llc $69,000
- Sec Clinical Research LLC $57,394
- Tribe Clinical Research Llc Mountain View Clinical Research $55,619
- Michigan Institute of Research $53,789
- Alliance for Multispecialty Research,llc $51,585
- Rio Clinical Trials, Llc $50,520
- Innovo Research Inc $49,871
- Acevedo Clinical Research Associates Co $47,233
- Leavitt Clinical Research Inc $44,981
- Helios Cr, Inc $41,487
- Caguas Clinical Research $41,072
- Innovo Research Llc $35,206
- Medical Research PArtners $32,613
- Coastal Carolina Research Center,incorporation $30,972
- Fomat Medical Research Inc $30,534
- Clinical Research PArtners, Llc $28,978
- Dade Research Center Llc $28,257
- Emda Clinical Research $24,200
- University of Missouri Health Care, MO $24,098
- Square 1 Clinical Research Inc $22,936
- Interspond Llc $22,417
- National Clinical Trials Inc $21,689
- Alliance for Multispecialty Research Llc $21,516
- Velocity Clinical Research,inc $16,350
- Prohealth Research Center Inc $15,597
- Pasadena Clinical Trials $14,000
- Houston Clinical Research Associates $14,000
- Bioresearch PArtner Holdings Lllp $12,669
- Tanner Memorial Clinic Tanner Clinic $12,373
- South Texas Clinical Research $11,382
- Snake River Research,pllc $10,393
- Inquest Clinical Research, Llc $9,034
- Riveldi Biomedical Research and Associates Miami Lakes $5,123
- Keypoint Clinical Research Llc $5,048
- Dfw Clinical Research $4,215
- Biomedical Research,llc $3,987
- Cotton Oneil Clinic Revocable Trust Cotton Oneil Clinical Research Center $3,518
- Velocity Clinical Research $2,466
- Monroe Biomedical Research Monroe $2,077
- Javara Inc $750
- $79
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.