Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
NCT07348692
This study is recruiting at 14 US sites in 9 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Pneumococcal Immunization
- Healthy Volunteers
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 42 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Sanofi
- Last updated on ClinicalTrials.gov
- October 5, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arkansas · 1
- Northwest Arkansas Pediatric Clinic- Site Number : 8400039 · Fayetteville, AR
California · 3
- Matrix Clinical Research - Huntington Park- Site Number : 8400029 · Huntington Park, CA
- Community Clinical Research- Site Number : 8400030 · Los Angeles, CA
- Matrix Clinical Research - Los Angeles- Site Number : 8400028 · Los Angeles, CA
Florida · 1
- PAS Research - Tampa- Site Number : 8400034 · Tampa, FL
Kentucky · 1
- Kentucky Pediatric Research- Site Number : 8400036 · Bardstown, KY
Michigan · 1
- Michigan Institute of Research- Site Number : 8400004 · Allen Park, MI
New York · 1
- Nappi Wellness Institute\t- Site Number : 8400037 · Syracuse, NY
South Carolina · 3
- Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 · Charleston, SC
- Parkside Pediatrics - Simpsonville- Site Number : 8400005 · Simpsonville, SC
- Tribe Clinical Research - Spartanburg- Site Number : 8400026 · Spartanburg, SC
Texas · 2
- PAS Research - Children's Care Clinic- Site Number : 8400035 · Edinburg, TX
- Pediatric Center - Richmond- Site Number : 8400038 · Richmond, TX
Utah · 1
- Rio Clinical Trials - Canyon View- Site Number : 8400031 · Ogden, UT
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.