This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days). The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations. • There will be 5 (for full-term infants) or 6 (for preterm infants) study visits: * Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days. * Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 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
1,092
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Investigational Site Number : 0560004
Alken, Belgium
Investigational Site Number : 0560001
Bruges, Belgium
Investigational Site Number : 0560002
Edegem, Belgium
Investigational Site Number : 0560005
Gozée, Belgium
Investigational Site Number : 0560007
Leuven, Belgium
Investigational Site Number : 0560003
Seroresponse rate for PCV21 and 15vPCV serotypes
Serotype specific IgG concentration ≥ 0.35 µg/mL
Time frame: 30 days post-toddler dose
IgG concentration for PCV21 and 15vPCV serotypes
Serotype specific IgG Geometric Mean Concentration (GMC)
Time frame: 30 days post-toddler dose
Anti- hepatitis B surface antigen (HBsAg) Ab
% Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)
Time frame: 30 days post-toddler dose
Anti- polyribosylribitol phosphate (PRP) Ab
% Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)
Time frame: 30 days post-toddler dose
Anti-poliovirus types (1, 2, and 3) Ab
% Antibody titers ≥ 1:8
Time frame: 30 days post-toddler dose
Anti-diphtheria Ab concentrations
% Antibody concentration ≥ 0.1 IU/mL
Time frame: 30 days post-toddler dose
Anti-tetanus Ab concentrations
% Antibody concentration ≥ 0.1 IU/mL
Time frame: 30 days post-toddler dose
Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
Antibody GMC
Time frame: 30 days post-toddler dose
Anti-measles Ab concentrations
Antibody GMC
Time frame: 30 days post-toddler dose
Anti-mumps Ab concentrations
Antibody GMC
Time frame: 30 days post-toddler dose
Anti-rubella Ab concentrations
Antibody GMC
Time frame: 30 days post-toddler dose
Anti-varicella Ab concentrations
Antibody GMC
Time frame: 30 days post-toddler dose
Anti HBsAg concentrations
% Antibody concentrations ≥ 10 mIU/mL
Time frame: 30 days post-primary series
Anti-PRP Ab concentrations
% Antibody concentrations ≥ 0.15 µg/mL
Time frame: 30 days post-primary series
Anti-poliovirus types (1, 2, and 3) Ab titers
% Antibody titers ≥ 1:8
Time frame: 30 days post-primary series
Anti-diphtheria Ab concentrations
% Antibody concentrations ≥ 0.1 IU/mL
Time frame: 30 days post-primary series
Anti-tetanus Ab concentrations
% Antibody concentrations ≥ 0.1 IU/mL
Time frame: 30 days post-primary series
Anti-pertussis Ab concentrations (PT and FHA)
Antibody GMC
Time frame: 30 days post-primary series
Serotype specific OPA titers for all serotypes included in PCV21
Antibody Geometric mean titer (GMT)
Time frame: 30 days post-primary series
Serotype specific OPA titers for all serotypes included in PCV21
Antibody GMT
Time frame: 30 days post-toddler dose
Presence of any immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Time frame: Within 30 minutes after each vaccine injection
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 20 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 20 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Roeselare, Belgium
Investigational Site Number : 2030001
Jindřichův Hradec, Czechia
Investigational Site Number : 2030009
Krnov, Czechia
Investigational Site Number : 2030006
Pilsen, Czechia
Investigational Site Number : 2030008
Prague, Czechia
...and 39 more locations