Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114-A; V114-B; Prevnar 13®
Intervention description: Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).; Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).; Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 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: Double (Participant, Investigator)
Enrollment: 690.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety, tolerability, and immunogenicity of a
      single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13®
      (pneumococcal 13-valent conjugate vaccine) in adult participants

      ≥50 years of age in good health.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Good health; any underlying chronic illness must be documented to be in stable
             condition

          -  Highly unlikely to conceive through 6 weeks after administration of the study vaccine

        Exclusion Criteria:

          -  Prior administration of any pneumococcal vaccine

          -  History of invasive pneumococcal disease (IPD) [positive blood culture, positive
             cerebrospinal fluid culture, or other sterile site) or known history of other
             culture-positive pneumococcal disease

          -  Known hypersensitivity to any vaccine component

          -  Known or suspected impairment of immune function

          -  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

          -  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

          -  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.

          -  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

          -  Breast feeding

          -  User of recreational or illicit drugs or has had a recent history (within the last
             year) of drug or alcohol abuse or dependence