Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Recruiting · Phase 3 · NCT07348692
Conditions: Pneumococcal Immunization, Healthy Volunteers
At a glance
- Research payments reported, 2025
- $60,054
- U.S. investigators named
- 4
- Sites paid
- 4
- Planned or actual enrollment
- 2,195
About the trial
- Sponsor
- Sanofi
- Tested
- PCV21 vaccine (biological), 20vPCV licensed vaccine (biological)
- Dates
- Started 2026-01-20; completion 2028-05-29
- Results posted
- Not yet
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formula…
From ClinicalTrials.gov, last updated 2026-10-05. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $60,054 in research payments for this study in 2025 (17 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
- Peyman Banooni, M.D. OB-GYN (Obstetrics & Gynecology) · Beverly Hills, CA
- Dean Moscovic, DO Pediatrics · Clarkston, MI
- Alexander Ryan, D.O. Internal Medicine · Lincoln, NE
- Richard L. Bennett JR., 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 $25,000
- Be Well Clinical Studies Llc $15,300
- Clinical Research PArtners, Llc $9,879
- Profound Research Llc $9,875
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.