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Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

StatusRecruiting
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 19 → 25 locations Eligibility criteria expanded, about 18 words · Secondary endpoints: details revised at 1 of 5 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Trial sites expanded: 6 → 19 locationsv6
  3. Trial sites expanded: 3 → 6 locationsv5
  4. Primary endpoint(s) modified Enrollment increased: 896 → 2195 participants · Primary completion moved earlier from Jan 19, 2028 to Jun 7, 2027 · Completion pushed from Jan 19, 2028 to May 29, 2028 · 2 morev4 Show 5 more changesShow less
    • Enrollment increased: 896 → 2195 participants
    • Primary completion moved earlier from Jan 19, 2028 to Jun 7, 2027
    • Completion pushed from Jan 19, 2028 to May 29, 2028
    • Interventions: 20vPCV licensed vaccine (Biological), Hepatitis A Vaccine (Biological), Measles Mumps and Rubella Vaccine (Biological), PCV21 vaccine… to 20vPCV licensed vaccine (Biological), PCV21 vaccine (Biological)
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 3 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Jan 26, 2026 to Jan 20, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Jan 26, 2026 to Jan 20, 2026
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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
Trial Details
NCT Number NCT07348692
Lead Sponsor Sanofi
Conditions Pneumococcal Immunization, Healthy Volunteers
Enrollment 2,195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov