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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
580
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular
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
Presence of any immediate adverse events (AEs)
Number of participants experiencing solicited and unsolicited immediate AEs
Time frame: Within 30 minutes after each vaccination
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
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Time frame: Through 30 days after each vaccine injection
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing SAEs
Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)
Number of participants experiencing AESIs
Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4
The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)
Time frame: 30 days PD4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 17 more locations