A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine 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. 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.
Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Birmingham, Alabama 35205, United States
Fullerton, California 92831, United States
Huntington Park, California 90255, United States
Los Angeles, California 90057, United States
Los Angeles, California 90057, United States
Lynwood, California 90262, United States
Palo Alto, California 94304, United States
Paramount, California 90723, United States
Sherman Oaks, California 91356-4173, United States
West Covina, California 91790, United States
Washington D.C., District of Columbia 20009, United States
Lexington, Kentucky 40536, United States
Louisville, Kentucky 40243, United States
Lafayette, Louisiana 70508, United States
Minneapolis, Minnesota 55402, United States
Lincoln, Nebraska 68504, United States
Lincoln, Nebraska 68505, United States
Lincoln, Nebraska 68516, United States
Lincoln, Nebraska 68522, United States
East Syracuse, New York 13057, United States
Syracuse, New York 13210, United States
Charlotte, North Carolina 28207, United States
Clyde, North Carolina 28721, United States
Statesville, North Carolina 28625, United States
Oklahoma City, Oklahoma 73103, United States
Simpsonville, South Carolina 29680, United States
Simpsonville, South Carolina 29681, United States
Spartanburg, South Carolina 29301, United States
Houston, Texas 77030, United States
Houston, Texas 77043, United States
Houston, Texas 77070, United States
Houston, Texas 77099, United States
Tomball, Texas 77375, United States
Pleasant View, Utah 84404, United States
Salt Lake City, Utah 84109, United States