Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevenar 13™; Vaxelis™; M-M-R®II; VARIVAX™
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.; Intramuscular 0.5 mL single dose; Subcutaneous 0.5 mL single dose; Subcutaneous 0.5 mL single dose
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1191.0
Sex: All
Minimum age: 70 Days
Maximum age: 111 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose
      schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine
      (PCV) as one of the currently recommended schedules by the World Health Organization (WHO)
      Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.

      The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared
      serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs)
      serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days
      following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114
      based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following
      Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™
      administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen
      included in Vaxelis™.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive,
             at the time of signing the informed consent.

          -  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:

          -  Was born prior to 37 weeks of gestation.

          -  Has a history of invasive pneumococcal disease (IPD) 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.

          -  Has a known or suspected impairment of immunological function.

          -  Has a history of congenital or acquired immunodeficiency.

          -  Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection.

          -  Has, or his/her mother has, a documented hepatitis B surface antigen - positive test.

          -  Has known or history of functional or anatomic asplenia.

          -  Has failure to thrive based on the clinical judgement of the investigator.

          -  Has a bleeding disorder contraindicating intramuscular vaccination.

          -  Has a history of autoimmune disease (including but not limited to systemic lupus
             erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid
             disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or
             other autoimmune disorders).

          -  Has a known neurologic or cognitive behavioral disorder, including
             encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development
             disorder, and related disorders.

          -  Has received a dose of any pneumococcal vaccine prior to study entry.

          -  Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based
             combination vaccine prior to study entry.

          -  Has received a dose of any acellular pertussis- or whole cell pertussis-based
             combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus
             vaccine, or any other combination thereof, prior to study entry.

          -  Has received a blood transfusion or blood products, including immunoglobulins.

          -  Has participated in another clinical study of an investigational product before the
             beginning or anytime during the duration of the current clinical study. Participants
             enrolled in observational studies may be included; these will be reviewed on a case
             by-case basis for approval by the Sponsor.

          -  Has any other reason that, in the opinion of the investigator, may interfere with the
             evaluation required by the study. Reasons may include, but are not limited to, being
             unable to keep appointments or planning to relocate during the study.

          -  Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is
             investigational site or Sponsor staff directly involved with this study.