PCV21 Vaccine's Phase 3 Trial in Pneumococcal Immunization Reads Out
ESTIMATED50% CONFIDENCEClinicalTrials.gov[1] lists 2027-06-07 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
Sanofi's phase 3 trial of PCV21 Vaccine in pneumococcal immunization reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 2,195 participants. 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
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