Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Active, not recruiting · Phase 3 · NCT06824194
Conditions: Pneumococcal Immunization
At a glance
- Research payments reported, 2025
- $2.6M
- U.S. investigators named
- 63
- Sites paid
- 51
- Planned or actual enrollment
- 2,360
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 2025-02-18; completion 2027-10-22
- Results posted
- Not yet
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine 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. 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 …
From ClinicalTrials.gov, last updated 2026-04-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $2.6M in research payments for this study in 2025 (350 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
- Max H. Hale, MD Pediatrics · Birmingham, AL
- William A. Nixon, MD Family Medicine · Guntersville, AL
- Kevin G. Rouse, M.D. Pediatrics · Jonesboro, AR
- Ibraheem Al Shareef, MD Pediatrics · Merced, CA
- Peyman Banooni, M.D. OB-GYN (Obstetrics & Gynecology) · Beverly Hills, CA
- Christine S. Girgis Family Medicine · Hawthorne, CA
- Wenhsiung L. Huang, M.D. Pediatrics · Brea, CA
- Juan A. Mocega, MD Pediatrics · Gardena, CA
- Aftab A. Naz, MD Pediatrics · Madera, CA
- Dmitriy Romanenko, M.D., OB-GYN (Obstetrics & Gynecology) · South Gate, CA
- James E. Saunders, MD Pediatrics · Lynwood, CA
- Ausberto B. Hidalgo General Practice · Pembroke Pines, FL
- Wendy J. Masterman, MD Pediatrics · Lutz, FL
- Julio D. Mendoza Molerio, MD Pediatric Emergency Medicine · Miami, FL
- Yael R. Elfassy, M.D. Pediatrics · Savannah, GA
- Jeffrey B. Baker, M.D. Family Medicine · Idaho Falls, ID
- Gary W. Soucie, MD Family Medicine · Blackfoot, ID
- Lilly H. Cheng-immergluck Pediatrics · Maywood, IL
- Alicia M. Wilson, D.O. Pediatrics · South Bend, IN
- John B. Blair, M.D. Pediatrics · Louisville, KY
- Kristina K. Bryant, MD Pediatric Infectious Disease · Louisville, KY
- Daniel J. Finn, MD Pediatrics · Bardstown, KY
- Mark A. Wurth, MD/PHD Pediatric Pulmonology · Lexington, KY
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- James D. Campbell, MD Pediatric Infectious Disease · Baltimore, MD
- Gabrielle N. Virgo, MD FAAP Pediatrics · Silver Spring, MD
- Alfred D. Johnson, MD Internal Medicine · Jefferson City, MO
- Lacy C. Hobgood, MD, FACP, FAAP Pediatrics · Greenville, NC
- Christine B. Turley, MD Pediatrics · Charlotte, NC
- Tyler B. Vereen, M.D. Pediatrics · Clyde, NC
- Luke F. Anschutz, M.D. Pediatrics · Lincoln, NE
- Paul D. Bernhardson, M.D. Pediatrics · Lincoln, NE
- Sahra Niazi, MD Pediatrics · Lincoln, NE
- Alexander Ryan, D.O. Internal Medicine · Lincoln, NE
- Kimberly M. White, MD, MS Pediatrics · Lincoln, NE
- Marcy A. Kulic, M.D. Adolescent Medicine · Henderson, NV
- Giancarlo R. Guido, M.D. Pediatrics · Bronx, NY
- Stephan A. Kohlhoff, M.D. Pediatric Infectious Disease · Brooklyn, NY
- George D. Vermenton, MD Pediatrics · Bronx, NY
- Leonard B. Weiner, MD Pediatric Infectious Disease · Syracuse, NY
- Frank A. Calcagno, MD Pediatrics · Gresham, OR
- Steven Twan, MD Pediatrics · Pittsburgh, PA
- Llanilys Justiz Hernandez, M.D. Pediatrics · Ponce, PR
- Nicolas Rosario Matos, M.D. Pediatrics · Bayamon, PR
- Yareri Soto-mendoza, M.D. Pediatrics · Morovis, PR
- Ismael Toro Grajales, MD, MPH Geriatric Medicine · Bayamon, PR
- Christopher M. Davis, DO Family Medicine · Greenville, SC
- Philip J. Mcgaha, MD Pediatrics · Charleston, SC
- Carole I. Mercer, M.D. Adolescent Medicine · Simpsonville, SC
- Justin S. Moll, M.D. Pediatrics · Greenville, SC
- Ashley Bose, MD Family Medicine · Edinburg, TX
- Amarnath Chamkur, M.D. Pediatrics · Houston, TX
- Gloria P. Heresi, M.D. Pediatric Infectious Disease · Houston, TX
- John P. Roberts, M.D. OB-GYN (Obstetrics & Gynecology) · Plano, TX
- Martin Yudovich, MD Pediatrics · Houston, TX
- Jason V. Church, MD Pediatrics · Pleasant View, UT
- Joshua D. Fuller, M.D. Pediatrics · Provo, UT
- Robert S. Hoki, M.D. Pediatrics · Layton, UT
- Daniel Neumann, M.D. Pediatrics · Roy, UT
- James T. Peterson, MD OB-GYN (Obstetrics & Gynecology) · Salt Lake City, UT
- Laurent C. Sigg, M.D. Pediatrics · Layton, UT
- Peter E. Silas, M.D. Pediatrics · Syracuse, UT
- John K. Scott, MD Family Medicine · Glen Allen, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Tribe Clinical Research Llc Mountain View Clinical Research $300,461
- Physicians Administrative Solutions Llc $275,010
- Midwest Childrens Health Research Institute,llc $159,843
- Alliance for Multispecialty Research,llc $104,097
- Wake Forest University Health Sciences $99,000
- Integrated Clinical Research Llc $94,842
- Brcr Medical Center Inc $91,253
- Madera Family Medical Group $90,271
- The Research Found of State University of New York $90,177
- Matrix Clinical Research,inc $84,581
- Qcare Site Services Inc $82,299
- University of Maryland Baltimore $72,836
- University of Texas Health Sciences Center at Houston $71,502
- Alliance for Multispecialty Research Llc $68,773
- Clinical Research Investigator Group Llc $67,898
- University of Chicago Medicine Psychiatry $67,748
- Natl Clinical Research Richmond Inc $63,855
- Kentucky Pediatric Research,inc $63,716
- Mercury Clinical Research $47,670
- Kentucky Pediatric Adult Research $46,752
- J Lewis Research,incorporation $39,480
- Advantage Clinical Trials $38,828
- Alabama Clinical Therapeutics Birmingham $38,432
- University of Louisville Research Found $36,079
- Elias Research Associates Llc $30,000
- Helios Cr, Inc $29,531
- Cognitive Clinical Trials Llc $29,403
- University of Texas Health Science Center at Houston $29,132
- Helping Hands Healthcare Corp $27,226
- Haywood Pediatric and Adolescent Medicine Group, PA $26,277
- East Carolina University Health Hemophilia Treatment Center $22,267
- Cenexel Iresearch Llc $21,733
- Interspond Llc $20,627
- The University of Texas Health Scie Center at Houston $19,754
- Fomat Medical Research Inc $19,000
- Be Well Clinical Studies Llc $18,810
- Velocity Clinical Research,inc $17,553
- Bluegrass Clinical Research,inc $14,003
- Lakeview Clinical Research $12,000
- Research Your Health $11,500
- Clinical Research Prime Idaho Fall Llc $11,068
- Alfa Medical Research Llc $11,000
- Activmed Practices and Research Llc $9,834
- Elite Clinical Trials Blackfoot $8,761
- Caribbean Medical Research Center Llc $8,500
- Velocity Clinical Research $5,075
- The Childrens Clinic of Jonesboro $3,711
- Advanced Investigative Medicine Inc $2,370
- University of Kentucky Research Fo $2,241
- Cyn3rgy Research $2,117
- Caribbean Research of Puerto Rico Llc $1,987
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.