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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,195
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Northwest Arkansas Pediatric Clinic- Site Number : 8400039
Fayetteville, Arkansas, United States
RECRUITINGMatrix Clinical Research - Huntington Park- Site Number : 8400029
Huntington Park, California, United States
RECRUITINGCommunity Clinical Research- Site Number : 8400030
Los Angeles, California, United States
RECRUITINGMatrix Clinical Research - Los Angeles- Site Number : 8400028
Los Angeles, California, United States
RECRUITINGPAS Research - Tampa- Site Number : 8400034
Tampa, Florida, United States
RECRUITINGKentucky Pediatric Research- Site Number : 8400036
Bardstown, Kentucky, United States
RECRUITINGMichigan Institute of Research- Site Number : 8400004
Allen Park, Michigan, United States
RECRUITINGTribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
Charleston, South Carolina, United States
RECRUITINGParkside Pediatrics - Simpsonville- Site Number : 8400005
Simpsonville, South Carolina, United States
RECRUITINGTribe Clinical Research - Spartanburg- Site Number : 8400026
Spartanburg, South Carolina, United States
RECRUITING...and 9 more locations
For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Time frame: 30 days after the third dose of PCV21 vaccine
For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL
Time frame: 30 days after the third dose of PCV21 vaccine
For all participants: Presence of any immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Time frame: Within 30 minutes after each vaccine injection
For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Time frame: Through 7 days after each vaccine injection
For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Time frame: Through 30 days after each vaccine injection
For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Number of participants experiencing SAEs and AESIs
Time frame: Throughout the study (through 6 months post-last vaccine injection)
Trial Transparency email recommended (Toll free for US & Canada)
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