The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Pneumococcal Conjugate Vaccine (V114); PNEUMOVAX® 23; PREVNAR 13®
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 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.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 692.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccines

Summary:

      The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia
      disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal
      Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR
      13®) when administered to healthy adults 50 years of age or older.

      The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean
      concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay
      at one month postvaccination in subjects who receive V114 will be noninferior to those
      measured in subjects who receive PNEUMOVAX® 23.
    

Eligibility criteria:

        Inclusion Criteria:

        -Without fever for 72 hours prior to vaccination

        Exclusion Criteria:

          -  Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate
             vaccine

          -  Known or suspected to be immunocompromised

          -  Functional or anatomic asplenia

          -  History of autoimmune disease

          -  Evidence of dementia or cognitive impairment

          -  Use of any immunosuppressive therapy

          -  Received a licensed non-live vaccine administered within the 14 days prior to receipt
             of study vaccine or scheduled to receive any other licensed vaccine within 30 days
             following receipt of study vaccine

          -  Received a licensed live virus vaccine within 30 days prior of receipt of study
             vaccine or is scheduled to receive any other licensed vaccine within 30 days of
             receipt of study vaccine

          -  Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of
             study vaccine

          -  Received a blood transfusion or blood products within the 6 months before receipt of
             study vaccine or scheduled to receive a blood transfusion or blood product within 30
             days of receipt of study vaccine

          -  History of invasive pneumococcal disease or known history of other culture-positive
             pneumococcal disease

          -  Received antibiotic therapy for any acute illness within 72 hours before receipt of
             study vaccine