Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13™
Intervention description: V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.; Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 253.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to assess the safety, tolerability, and immunogenicity of V114
      compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated
      with 23-valent pneumococcal polysaccharide vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is in good health (any underlying chronic illness must be documented to be in stable
             condition)

          -  Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1
             year prior to study entry

          -  Is a male or postmenopausal female

        Exclusion Criteria:

          -  Has received prior administration of any pneumococcal vaccine other than 23-valent
             pneumococcal polysaccharide vaccine

          -  Has a history of invasive pneumococcal disease or known history of other
             culture-positive pneumococcal disease

          -  Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine,
             or any diphtheria toxoid-containing vaccine

          -  Is known or suspected impairment of immune function

          -  Has received systemic corticosteroids for >=14 consecutive days and has not completed
             treatment <=30 days prior to study entry, or received systemic corticosteroids
             exceeding physiologic replacement doses within 14 days prior to study vaccination

          -  Has a coagulation disorder contraindicating intramuscular vaccination

          -  Receives immunosuppressive therapy, including chemotherapeutic agents used to treat
             cancer or other conditions, and treatments associated with organ or bone marrow
             transplantation, or autoimmune disease

          -  Has received a blood transfusion or blood products, including immunoglobulins within
             the 6 months before receipt of study vaccine or is scheduled to receive a blood
             transfusion or blood product within 30 days of receipt of study vaccine. Autologous
             blood transfusions are not considered an exclusion criterion

          -  Has participated in another clinical study of an investigational product within 2
             months before the beginning of or any time during the duration of the current clinical
             study

          -  Is a user of recreational or illicit drugs or has had a recent history (within the
             last year) of drug or alcohol abuse or dependence.