Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13®
Intervention description: V114 15-valent PCV containing 13 serotypes present in Prevnar 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 IM administration; Prevnar 13® 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 IM 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: 606.0
Sex: All
Minimum age: 7 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect
      to the proportion of participants with adverse events (AEs) and 2) to evaluate the
      anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric
      Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group.
      There is no formal hypothesis testing in this study.
    

Eligibility criteria:

        Inclusion Criteria

          -  Not be pregnant or breastfeeding

          -  Not be a woman of childbearing potential

          -  If of a woman of childbearing potential, agree to follow the contraceptive guidance
             during the treatment period and for at least 6 weeks after the last dose of study
             intervention

          -  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)

          -  Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing
             vaccine

          -  Had a recent febrile illness occurring within 72 hours prior to receipt of study
             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

          -  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 known neurologic or cognitive behavioral disorder, including
             encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development
             disorder, and related disorders

          -  Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to
             study entry based on medical record. Participants ≥2 years of age could have received
             a PCV at least 8 weeks prior to study entry as follows: a partial regimen of
             Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based
             on local guidelines. Participants should not have received any dose of a pneumococcal
             polysaccharide vaccine

          -  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/day for persons weighing >10 kg) for ≥14 consecutive days and has
             not completed this course of treatment at least 30 days prior to the first dose of
             study vaccine at randomization; has received or is expected to receive systemic
             corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day
             prednisone equivalent) within 14 days prior to any dose of study vaccine; or is
             expected to require systemic corticosteroids within 30 days after any study
             vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled
             steroids are permitted)

          -  Has received other licensed non-live vaccines within 14 days before receipt of study
             vaccine. Exception: Inactivated influenza vaccine may be administered but must be
             given at least 7 days before receipt of study vaccine or at least 15 days after
             receipt of study vaccine

          -  Has received a licensed live vaccine within 30 days before receipt of study vaccine

          -  Has received a blood transfusion or blood products, including immunoglobulins, within
             6 months before receipt 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