A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™
Intervention description: V114 pneumococcal capsular polysaccharide 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; Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose
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: 2409.0
Sex: All
Minimum age: 42 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in
      healthy infants. This study will include both full-term infants (≥37 weeks gestational age)
      and premature infants (<37 weeks gestational age). Premature infants will be included in a
      Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety
      following administration of V114 or Prevnar 13™.
    

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 approximately 2 months of age, from 42 days to 90 days inclusive, at
             the time of obtaining the informed consent

          -  Have 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:

          -  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

          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or
             any diphtheria toxoid containing vaccine

          -  Known or suspected impairment of immunological function

          -  History of congenital or acquired immunodeficiency

          -  Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

          -  Known or history of functional or anatomic asplenia

          -  Failure to thrive based on the clinical judgment of the investigator

          -  Known coagulation disorder contraindicating intramuscular vaccination

          -  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)

          -  Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis,
             acute disseminating encephalomyelitis, pervasive development disorder, and related
             disorders

          -  Received a dose of any pneumococcal vaccine prior to study entry

          -  Received a blood transfusion or blood products, including immunoglobulins, before
             receipt of first dose of study vaccine

          -  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.

          -  Has any other reason that, in the opinion of the investigator, may interfere with the
             evaluation required by the study

          -  Has an immediate family member who is investigational site or Sponsor staff directly
             involved with this study.