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Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
Sponsor: Sanofi
Summary
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series in infants aged from approximately 2 months (42 to 89 days). The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). 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 until 15 months of age, V06 separated from V05 by 30 days.
Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
Key Details
Gender
All
Age Range
42 Days - 89 Days
Study Type
INTERVENTIONAL
Enrollment
580
Start Date
2025-02-27
Completion Date
2027-09-10
Last Updated
2026-02-13
Healthy Volunteers
Yes
Conditions
Interventions
PCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Prevnar 20 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
M-M-R II vaccine
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Rotarix
Pharmaceutical form:Solution-Route of administration:Oral
RotaTeq
Pharmaceutical form:Solution-Route of administration:Oral
Vaxelis vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Varivax
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Priorix
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
VAQTA
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Havrix
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Locations (27)
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025
Los Angeles, California, United States
The Medici Medical Research- Site Number : 8400008
Hollywood, Florida, United States
Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027
Miami, Florida, United States
Atlantis Clinical Research- Site Number : 8400009
Miami, Florida, United States
Velocity Clinical Research - Sioux City- Site Number : 8400007
Sioux City, Iowa, United States
Private Practice - Dr. Michael W. Simon- Site Number : 8400001
Lexington, Kentucky, United States
Velocity Clinical Research - New Orleans- Site Number : 8400006
New Orleans, Louisiana, United States
Finger Lakes Medical Research - Cortland- Site Number : 8400022
Cortland, New York, United States
University of Rochester Medical Center- Site Number : 8400019
Rochester, New York, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400015
Syracuse, New York, United States
Kid's Way Pediatrics- Site Number : 8400013
Hermitage, Pennsylvania, United States
Carolina Family Care - Charleston- Site Number : 8400014
Charleston, South Carolina, United States
Helios Clinical Research - BUR PEDI- Site Number : 8400016
Burleson, Texas, United States
Clinsearch Inc at VAST Clinical Research- Site Number : 8400028
Euless, Texas, United States
DM Clinical Research - Houston - Jones Road- Site Number : 8400012
Houston, Texas, United States
University of Texas Medical Branch at Galveston- Site Number : 8400005
League City, Texas, United States
Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024
Stephenville, Texas, United States
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 4840003
León, Guanajuato, Mexico
Investigational Site Number : 4840001
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840002
Temixco, Morelos, Mexico
Investigational Site Number : 4840004
Tlaltizapán, Morelos, Mexico
Investigational Site Number : 6080001
Cebu City, Philippines
Investigational Site Number : 6080002
Quezon City, Philippines
Investigational Site Number : 6080003
Quezon City, Philippines