Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; Prevnar 13®
Intervention description: 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in each 0.5 mL dose.
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: 1205.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to
      compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar
      13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the
      serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared
      serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured
      by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has good health in the opinion of the investigator. Any underlying chronic
             condition must be documented to be in stable condition according to the investigator's
             judgment.

          -  Male or female ≥50 years of age at the time of signing the informed consent. (For
             Japan only: Is male or female ≥65 years of age at the time of signing the informed
             consent)

          -  Contraceptive use by women should be consistent with local regulations regarding the
             methods of contraception for those participating in clinical studies.

          -  Female participant is eligible to participate if she is not pregnant, not
             breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who
             agrees to use agreed upon contraception during the treatment period and for at least 6
             weeks after the last dose of study intervention.

          -  Provides written informed consent for the study. The participant may also provide
             consent for future biomedical research. However, the participant may participate in
             the main study without participating in future biomedical research.

        Exclusion Criteria:

          -  History of invasive pneumococcal disease (IPD) (positive blood culture, positive
             cerebrospinal fluid culture, or positive culture at another sterile site) or known
             history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day
             1).

          -  Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
             pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine.

          -  Known or suspected impairment of immunological function including, but not limited to,
             a history of congenital or acquired immunodeficiency, documented human
             immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of
             autoimmune disease.

          -  Coagulation disorder contraindicating intramuscular (IM) vaccinations.

          -  Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or
             axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for
             any acute illness occurring within 72 hours before receipt of study vaccine.

          -  History of malignancy ≤5 years prior to signing informed consent, except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

          -  A WOCBP who has a positive urine or serum pregnancy test before the first vaccination
             at Visit 1 (Day 1).

          -  Has received any pneumococcal vaccine or is expected to receive any pneumococcal
             vaccine during the study outside of the protocol.

          -  Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14
             consecutive days and has not completed intervention at least 30 days before study
             entry.

          -  Has received systemic corticosteroids exceeding physiologic replacement doses
             (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
             (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon
             steroid injections], and inhaled/nebulized steroids are permitted.)

          -  Is receiving immunosuppressive therapy, including chemotherapeutic agents used to
             treat cancer or other conditions, and interventions associated with organ or bone
             marrow transplantation, or autoimmune disease.

          -  Has received any non-live vaccine within the 14 days before receipt of any study
             vaccine or is scheduled to receive any non-live vaccine within 30 days following
             receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be
             administered but must be given at least 7 days before receipt of any study vaccine or
             at least 15 days after receipt of any study vaccine.)

          -  Has received any live vaccine within 30 days before receipt of any study vaccine or is
             scheduled to receive any live vaccine within 30 days following receipt of any study
             vaccine.

          -  Has received a blood transfusion or blood products, including immunoglobulin, 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.

          -  Currently participating in or has participated in an interventional clinical study
             with an investigational compound or device within 2 months of participating in this
             current study.

          -  In the opinion of the investigator, has a history of clinically relevant drug or
             alcohol use that would interfere with participation in protocol-specified activities.

          -  History or current evidence of any condition, therapy, laboratory abnormality, or
             other circumstance that might expose the participant to risk by participating in the
             study, confound the results of the study, or interfere with the participant's
             participation for the full duration of the study.

          -  An immediate family member (e.g., spouse, parent/legal guardian, sibling, or child)
             who is investigational site or Sponsor staff directly involved with this study.