A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114 Aluminum-adjuvanted; V114 Non-adjuvanted; Prevnar 13®
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 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 (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1152.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Invasive pneumococcal disease; Pneumonia; Pneumococcal conjugate vaccine

Summary:

      This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of
      the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune
      responses to the 13 serotypes in common Prevnar 13®
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy infants ≥ 42 days to ≤ 89 days.

          -  Participant's parent/legal guardian understands the study procedures, alternate
             treatments available and risks involved with the study, and voluntarily agrees to
             allow the child to participate by giving written informed consent.

          -  Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C
             (<100.0°F) on day of vaccination.

          -  Participant's parent/legal guardian is able to read, understand, and complete study
             questionnaires (i.e., the Vaccination Report Card).

          -  Participant is able to attend all scheduled visits and to comply with the study
             procedures.

          -  Participant's parent/legal guardian has access to a telephone.

        Exclusion Criteria:

          -  Prior administration of any pneumococcal vaccine.

          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine.

          -  Known or suspected impairment of immunological function.

          -  Participant has a history of congenital or acquired immunodeficiency (e.g.,
             splenomegaly).

          -  Participant or his/her mother has documented human immunodeficiency virus (HIV)
             infection.

          -  Functional or anatomic asplenia.

          -  History of autoimmune disease including multiple sclerosis (MS), systemic lupus,
             polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis,
             Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.

          -  Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS),
             MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis,
             pervasive developmental disorder, and related disorders.

          -  Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are
             permitted). Participants on intramuscular, oral, or intravenous corticosteroid
             treatment should be excluded if they are receiving or expected to receive in the
             period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2
             mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh
             more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive
             therapies also include chemotherapeutic agents used to treat cancer or other
             conditions, and treatments associated with organ or bone marrow transplantation, or
             autoimmune disease.

          -  Participant has received other licensed non-live vaccines within the 14 days before
             receipt of study vaccine.

          -  Participant has received a licensed live virus vaccine within the 30 days prior of
             receipt of study vaccine.

          -  Prior receipt of a blood transfusion or blood products, including immunoglobulins.

          -  Investigational drugs or vaccines received within the 2 months before receipt of study
             vaccine.

          -  Participation in another clinical study within 42 days before the beginning or anytime
             during the duration of the current clinical study.

          -  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.

          -  A recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 72
             hours before receipt of study vaccine.

          -  History of failure to thrive.

          -  Participant has a coagulation disorder contraindicating IM vaccination.

          -  Participant and his/her mother have documented hepatitis B surface antigen-positive.

          -  Any infant who cannot be adequately followed for safety according to the protocol
             plan.

          -  Participant's parent/legal guardian is unlikely to adhere to study procedures, keep
             appointments, or is planning to relocate during the study.

          -  Any other reason that in the opinion of the investigator may interfere with the
             evaluation required by the study.