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

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Sanofi
Study ID
NCT07348692
Phase
PHASE3
Status
Recruiting
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Conditions

  • Healthy Volunteers
  • Pneumococcal Immunization

Eligibility Criteria

Sex
ALL
Age
42 Days - 89 Days
Healthy Volunteers
Accepted

Interventions

  • PCV21 vaccine — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
  • 20vPCV licensed vaccine — BIOLOGICAL
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Study Details

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

Key Dates

Start date
Jan 20, 2026
Status verified
May 2026
Primary completion
Jun 7, 2027
Completion
May 29, 2028

Study Design

Enrollment
2,195 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1: PCV21
    Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Experimental: Group 2: PCV21
    Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Experimental: Group 3: PCV21
    Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Active Comparator: Group 4: 20vPCV (Cohort A only)
    Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

Primary Outcome Measure

For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC) [ Time Frame: 30 days after the third dose of PCV21 vaccine ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (13)

FacilityCityStateZIPSite coordinators
Northwest Arkansas Pediatric Clinic- Site Number : 8400039FayettevilleArkansas72703-
Matrix Clinical Research - Huntington Park- Site Number : 8400029Huntington ParkCalifornia90255-
Community Clinical Research- Site Number : 8400030Los AngelesCalifornia90008-
Matrix Clinical Research - Los Angeles- Site Number : 8400028Los AngelesCalifornia90057-
PAS Research - Tampa- Site Number : 8400034TampaFlorida33613-
Kentucky Pediatric Research- Site Number : 8400036BardstownKentucky40004-
Michigan Institute of Research- Site Number : 8400004Allen ParkMichigan48101-
Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008CharlestonSouth Carolina29407-
Parkside Pediatrics - Simpsonville- Site Number : 8400005SimpsonvilleSouth Carolina29681-
Tribe Clinical Research - Spartanburg- Site Number : 8400026SpartanburgSouth Carolina29301-
PAS Research - Children's Care Clinic- Site Number : 8400035EdinburgTexas78539-
Pediatric Center - Richmond- Site Number : 8400038RichmondTexas77469-
Rio Clinical Trials - Canyon View- Site Number : 8400031OgdenUtah84404-

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Northwest Arkansas Pediatric Clinic· Fayetteville, ARMatrix Clinical Research - Huntington Park· Huntington Park, CACommunity Clinical Research· Los Angeles, CAMatrix Clinical Research - Los Angeles· Los Angeles, CAPAS Research - Tampa· Tampa, FLKentucky Pediatric Research· Bardstown, KY

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