The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).
The duration of each participation will be approximately 9 to 11 months for each infant participant, 8 to 9 months for each toddler participant, and 6 months for each child/adolescent participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,268
Number of participants reporting immediate adverse events (AEs)
Unsolicited (spontaneously reported) systemic AEs after each and any injection of a pneumococcal vaccine
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and solicited systemic reactions
Time frame: Up to Day 7 post-vaccination
Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine
Time frame: Within 30 days after vaccination
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
SAEs and AESIs are collected throughout the study period
Time frame: From day 0 to day 517
Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific IgG concentrations for all serotypes included in PCV21
Ab (antibody) concentrations for each pneumococcal serotype are measured.
Time frame: On day 30 after last vaccination
Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype are determined.
Time frame: On day 30
Number of Children (2-5 years of age [YoA]):with serotype specific IgG concentrations for all serotypes included in PCV21
Ab concentrations for each pneumococcal serotype are measured.
Time frame: On day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site # 8400008
Paramount, California, United States
Site # 8400024
Doral, Florida, United States
Site # 8400007
Hialeah, Florida, United States
Site # 8400014
Melbourne, Florida, United States
Site # 8400009
Miami, Florida, United States
Site # 8400016
Miami, Florida, United States
Site # 8400021
Fayetteville, Georgia, United States
Site # 8400004
Union City, Georgia, United States
Site # 8400003
Sioux City, Iowa, United States
Site # 8400023
Erlanger, Kentucky, United States
...and 28 more locations
Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype are determined.
Time frame: On day 30
Number of Children/adolescents (≥ 2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21
Serotype specific OPA titers for each pneumococcal serotype are determined.
Time frame: On day 30
Number of Children/adolescents (≥ 2 YoA): with serotype specific IgG concentrations for all serotypes included in PCV21
Ab concentrations for each pneumococcal serotype are measured.
Time frame: On day 30
Number of participants (all age groups) with serotype specific IgG concentration ≥ 0.35 μg/mL for all serotypes included in PCV21
Ab concentrations for each pneumococcal serotype are measured.
Time frame: On day 30 after last vaccination
Number of infants (7-11 MoA) and toddlers(12-23 MoA):with serotype specific OPA titers for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype are determined.
Time frame: On day 30 after last vaccination
Percentage of infants (7-11 MoA) and toddlers(12-23 MoA): with serotype specific OPA titers ≥ LLOQ for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype included in the PCV21 formulations are determined. The following threshold values will be considered: ≥ lower limit of quantitation (LLOQ)
Time frame: On day 30 after last vaccination
Number of Children/adolescents (6-17 YoA):with serotype specific IgG concentrations for all serotypes included in PCV21
Ab concentrations for each pneumococcal serotype are measured.
Time frame: On day 30