Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Prevnar 13™; Pneumovax™ 23; Placebo
Intervention description: Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.; Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.; Injections are to be administered into the deltoid muscle of the upper arm.
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: 400.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and immunogenicity of sequential
      administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and
      older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to
      pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as
      measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and
      Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and
      placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as
      measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by
      Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any chronic illness must be documented to be in stable condition

          -  Male, or a female agrees to remain abstinent, or use, or have their partner use, 2
             acceptable methods of contraception through 6 weeks after receiving study vaccination;
             or a female who is not of reproductive potential

        Exclusion Criteria:

          -  Is or has an immediate family member who is investigational site or sponsor staff
             directly involved with this trial

          -  Prior administration of any pneumococcal vaccine

          -  History of invasive pneumococcal disease

          -  Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of
             the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine

          -  Known or suspected impairment of immunological function, documented Human
             Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease

          -  Received systemic corticosteroids (equivalent of >=2 mg/kg total daily dose of
             prednisone or >=20 mg/kg for persons weighing >10 kg) for >=14 consecutive days and
             has not completed treatment <=30 days before study vaccination, or has received
             systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone
             equivalent) within 14 days before study vaccination (topical, ophthalmic,
             intra-articular, and inhaled/nebulized steroids are permitted).

          -  Has a coagulation disorder contraindicating intramuscular vaccination

          -  Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat
             cancer or other conditions, and treatments associated with organ or bone marrow
             transplantation or autoimmune disease

          -  Received a blood transfusion or blood products, including immunoglobulins <=6 months
             before receiving study vaccine, or is scheduled to receive them within 30 days

          -  Participated in another clinical study of an investigational product <=2 months before
             or during the current study

          -  Is breast-feeding