A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: Pneumovax™ 23
Intervention description: Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in
      participants from the Russian population who are 50 years of age and older or 2 to 49 years
      of age and at increased risk for pneumococcal disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  For participants 50 years of age or older: any underlying chronic illness must be in
             stable condition

          -  For participants 2 to 49 years of age: participant has an increased risk for
             pneumococcal disease as a result of one of the following: chronic cardiovascular
             disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver
             disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell
             anemia, living in a special environment or social setting such as crowded, closed
             communities

          -  Male, or female not of reproductive potential, or female of reproductive potential who
             agrees to remain abstinent or to use 2 acceptable methods of contraception through 6
             weeks after study vaccination

        Exclusion Criteria:

          -  Received prior vaccination with pneumococcal vaccine

          -  Has known or suspected immune dysfunction or conditions associated with
             immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term
             systemic corticosteroids

          -  Has history of autoimmune disease

          -  Received a licensed live virus vaccine within 3 months before or is scheduled within 3
             months after study vaccination

          -  Received a licensed inactivated vaccine within 28 days before or is scheduled within
             28 days after study vaccination

          -  Received an investigational drug or other investigational vaccine within 2 months
             before or is scheduled within 28 days after study vaccination (3 months if a live
             virus vaccine)

          -  Received any blood product or immunoglobulin preparation within 6 months before or 28
             days after study vaccination

          -  Hospitalized for acute illness within 3 months before study vaccination

          -  Is a pregnant woman or nursing mother

          -  History of invasive pneumococcal disease or of other culture-positive pneumococcal
             disease

          -  History of fever illness within 3 days before study vaccination

          -  Received antibiotic therapy for any acute illness within 7 days before study
             vaccination

          -  Hypersensitivity to any components of the vaccine, including phenol