Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Rotarix™; Infanrix™ hexa; V114; Prevenar 13™
Intervention description: Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2); Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13); 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,; 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.
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: 1184.0
Sex: All
Minimum age: 42 Days
Maximum age: 90 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and tolerability and immunogenicity of V114 when
      administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to
      Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response
      rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2
      serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior
      to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on
      anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean
      concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2
      serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy

          -  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

          -  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

          -  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 influenzae type b conjugate vaccine, poliovirus
             vaccine, rotavirus 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

          -  Is or has an immediate family member (eg, parent/legal guardian or sibling) who is
             investigational site or Sponsor staff directly involved with this study