Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Intervention: V116; PNEUMOVAX™23
Intervention description: Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution; Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the safety, tolerability, and immunogenicity of a
      polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy
      Japanese adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is a healthy Japanese male or female ≥20 years of age at time of randomization

          -  male participants must agree to be abstinent or use contraception during the
             intervention period and for ≥30 days after the last dose of study intervention

          -  female participants must not be pregnant or breastfeeding, and is either:

          -  not a woman of childbearing potential (WOCBP) or

          -  a WOCBP who agrees to remain abstinent or use contraception during the intervention
             period and for ≥30 days after the last dose of study intervention

        Exclusion Criteria:

          -  has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1

          -  has a known hypersensitivity to any vaccine components

          -  has impaired immunological function

          -  has a coagulation disorder

          -  had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72
             hours before Day 1

          -  has a known malignancy that is progressing/requiring treatment

          -  has received, or is expected to receive, a pneumococcal vaccine outside the study
             protocol

          -  has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14
             consecutive days and has not completed the regimen for ≥30 days prior to Day 1

          -  is receiving immunosuppressive therapy

          -  has received any non-live vaccine from 14 days prior to Day 1 other than inactivated
             influenza vaccine

          -  has received any live vaccine from 30 days prior to Day 1

          -  has received a blood transfusion or blood products

          -  has participated in another clinical trial within 2 months of this study

          -  has clinically relevant drug or alcohol abuse

          -  has any condition that, in the opinion of the investigator, precludes participation in
             this study