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Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
Sponsor: Sanofi
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
42 Days - 89 Days
Study Type
INTERVENTIONAL
Enrollment
2195
Start Date
2026-01-20
Completion Date
2028-05-29
Last Updated
2026-04-01
Healthy Volunteers
Yes
Interventions
PCV21 vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
20vPCV licensed vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Locations (3)
Investigational Site Number : 3400001
San Pedro Sula, Honduras
Investigational Site Number : 3400002
Tegucigalpa, Honduras
Investigational Site Number : 3400003
Tegucigalpa, Honduras