A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™; PNEUMOVAX™23
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 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) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose; 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) 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: Double (Participant, Investigator)
Enrollment: 652.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114
      and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar
      13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes
      contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either
      V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal
      hypothesis testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female in good health

          -  Female participant: not pregnant, not breastfeeding and 1) not of childbearing
             potential, or 2) of childbearing potential and agrees to practice contraception
             through 6 weeks after administration of last study vaccine.

        Exclusion Criteria

          -  History of invasive pneumococcal disease

          -  Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
             pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.

          -  Known or suspected impairment of immune function

          -  Coagulation disorder contraindicating intramuscular vaccination

          -  History of malignancy ≤5 years before enrollment, except for adequately treated basal
             cell or squamous cell skin cancer or in situ cervical cancer

          -  Female participant: positive urine or serum pregnancy test

          -  Prior administration of any pneumococcal vaccine

          -  Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14
             consecutive days and has not completed intervention at least 30 days before study
             entry.

          -  Received systemic corticosteroids exceeding physiologic replacement doses
             (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
             (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon
             steroid injections], and inhaled/nebulized steroids are permitted).

          -  Received immunosuppressive therapy

          -  Received a blood transfusion or blood products within 6 months of enrollment

          -  Participated in another clinical study of an investigational product within 2 months
             of enrollment

          -  Current user of recreational or illicit drugs or history of drug or alcohol abuse or
             dependence.