Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
Condition: Pneumococcal Infections; Pneumococcal Vaccines
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™; RotaTeq™; Pentacel™; RECOMBIVAX HB™; VAQTA™; MMR II™; VARIVAX™; HIBERIX™
Intervention description: V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.; Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.; A total of 3 RotaTeq™ 2 mL oral dosings at ~2, ~4, and ~6 months of age.; A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.; A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.; One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.; One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.; One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.; One HIBERIX™ 0.5 mL IM dosing at Visit 5.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1720.0
Sex: All
Minimum age: 42 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114
      in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™
      for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days
      following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes
      based on the response rate of the 2 unique V114 serotypes compared with the lowest response
      rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days
      following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on
      anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric
      mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar
      13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the
      2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in
      Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to
      Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs
      serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to
      Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of
      the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes
      in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is healthy (based on a review of medical history and physical examination) in the
             clinical judgement of the investigator

          -  Has a legally acceptable representative who understands the study procedures,
             alternate treatments available, and risks involved with the study and voluntarily
             agrees to participate by giving written informed consent.

        Exclusion Criteria:

          -  Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive
             cerebrospinal fluid culture, or other sterile site) or known history of other culture
             positive pneumococcal disease.

          -  Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine
             (PCV), any component of the licensed pediatric vaccines to be administered
             concomitantly in the study, or any diphtheria toxoid-containing vaccine.

          -  Has any contraindication to the concomitant study vaccines being administered in the
             study.

          -  Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary
             temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study
             vaccine.