A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Prevnar 13™; V114; RotaTeq™; Pentacel™; RECOMBIVAX HB™; HIBERIX™; M-M-R™ II; VARIVAX™
Intervention description: Prevnar 13™ contains the 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 given via IM injection.; V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.; RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.; Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.; M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.; VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 900.0
Sex: All
Minimum age: 42 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the
      Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from
      Prevnar 13™ to V114 during the four-dose PCV immunization schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is Healthy, based on clinical judgment 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 (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

          -  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 judgment of the investigator

          -  Has a known coagulation 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 rotavirus vaccine 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

          -  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 (e.g., parent/legal guardian or sibling) who is
             investigational site or Sponsor staff directly involved with this study.