Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Pneumococcal 13-valent Conjugate Vaccine (PCV13); Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) 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.; Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 3 Months
Maximum age: 3 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal Vaccines

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114
      administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy (based on a review of medical history and physical examination) based on the
             clinical judgment of the investigator.

          -  Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of
             age), at the time of obtaining 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:

          -  Has a history of invasive pneumococcal disease (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 vaccines, any component of the pneumococcal conjugate
             vaccine or any diphtheria toxoid-containing vaccine

          -  Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis,
             inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to
             approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).

          -  Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours
             prior to receipt of study vaccine.

          -  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 hepatitis B surface antigen - positive test.

          -  Has a known functional or anatomic asplenia.

          -  Has failure to thrive based on the clinical judgement of the investigator.

          -  Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular
             vaccination.

          -  Has a history of autoimmune disease (including but not limited to systemic lupus
             erythematosus, antiphospholipid syndrome, Bechet'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 and/or DTaP-IPV vaccine (or vaccine containing
             any DTaP-IPV component) prior to study entry.

          -  Meets one or more of the following systemic corticosteroid exclusion criteria: has
             received systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of
             prednisone or ≥ 20 mg/d for persons weighing > 10 kg) for ≥ 14 consecutive days and
             has not completed this course of treatment at least 30 days prior to trial
             randomization, has received systemic corticosteroids within 14 days prior to the first
             dose of study vaccine at randomization, and is expected to require systemic
             corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d
             for persons weighing > 10 kg) for ≥ 14 consecutive days within 14 days prior to or 30
             days after each vaccination during conduct of the study.(Topical, ophthalmic and
             inhaled steroids are permitted.)

          -  Has received other licensed non-live vaccines within the 14 days before receipt of
             first dose of study vaccine.

          -  Has received a licensed live virus vaccine within the 28 days before receipt of first
             dose of study vaccine.

          -  Has received a blood transfusion or blood products, including immunoglobulins before
             receipt of first dose of study vaccine.

          -  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. (Refer to the Vaccination Guideline in Japan).
             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., spouse, parent/legal guardian, sibling, or
             child) who is investigational site or Sponsor staff directly involved with this study.