Condition: Pneumococcal Immunization · Healthy Volunteers · Sponsor: Sanofi
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 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). 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 days, V05 at 12 months of age, V06 separated from V05 by 30 days
This description comes directly from the study's public registry record.
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
Always discuss trial participation with your own doctor first.
| Northwest Arkansas Pediatric Clinic- Site Number : 8400039 | Fayetteville, Arkansas, United States | Recruiting |
| Matrix Clinical Research - Huntington Park- Site Number : 8400029 | Huntington Park, California, United States | Recruiting |
| Community Clinical Research- Site Number : 8400030 | Los Angeles, California, United States | Recruiting |
| Matrix Clinical Research - Los Angeles- Site Number : 8400028 | Los Angeles, California, United States | Recruiting |
| PAS Research - Tampa- Site Number : 8400034 | Tampa, Florida, United States | Recruiting |
| Kentucky Pediatric Research- Site Number : 8400036 | Bardstown, Kentucky, United States | Recruiting |
| Michigan Institute of Research- Site Number : 8400004 | Allen Park, Michigan, United States | Recruiting |
| Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008 | Charleston, South Carolina, United States | Recruiting |
| Parkside Pediatrics - Simpsonville- Site Number : 8400005 | Simpsonville, South Carolina, United States | Recruiting |
| Tribe Clinical Research - Spartanburg- Site Number : 8400026 | Spartanburg, South Carolina, United States | Recruiting |
| PAS Research - Children's Care Clinic- Site Number : 8400035 | Edinburg, Texas, United States | Recruiting |
| Pediatric Center - Richmond- Site Number : 8400038 | Richmond, Texas, United States | Recruiting |
+ 7 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07348692