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.
- Start
- Jun 7, 202750% CONFIDENCEfrom the source
PCV21 Vaccine's Phase 3 Trial in Pneumococcal Immunization Reads Out
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
- The read-out is the estimated primary completion of Sanofi's NCT07348692, "A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers"[1]
- Primary completion is estimated for 2027-06-07 and overall completion for 2028-05-29; the trial started 2026-01-20 (actual), was first posted 2026-01-16, and the record's status is RECRUITING as of the last update posted 2026-05-22[1]
- Estimated enrolment is 2,195 healthy infants from approximately 2 months of age (42 to 89 days)[1]
- The study measures whether 3 lots of the investigational vaccine PCV21 raise antibodies "in a similar way (ie, same immune response)" and are safe compared with a licensed 20-valent pneumococcal vaccine (20vPCV, Prevnar 20)[1]
- Cohort A randomizes approximately 896 participants to three PCV21 formulation groups or the 20vPCV comparator (Groups 1-4); Cohort B randomizes approximately 1,299 to the three PCV21 formulation groups only (Groups 1-3)[1]
- Vaccines are given intramuscularly at approximately 2, 4, 6 and 12 months of age over 6 study visits, with study duration per participant of up to approximately 17 months[1]
- The primary outcome measure for all participants is serotype-specific IgG geometric mean concentration 30 days after the third dose of PCV21 vaccine[1]
- The trial runs at 19 sites in the United States, Honduras and Puerto Rico[1]
References 150% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]50%clinicaltrials.gov/study/NCT07348692clinicaltrials.gov· Posted Sep 20, 2026· Starts Jun 7, 2027 ✓· 100% of score
ClinicalTrials.gov lists 2027-06-07 as the estimated primary completion date; a sponsor's estimate, and trials of this size routinely slip.
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