A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: V114; QIV; Matching Placebo for V114
Intervention description: Single 0.5 mL injection; Single 0.5 mL injection; Single 0.5 mL injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1200.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was designed to evaluate the safety and tolerability of a single dose of V114 when
      administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza
      vaccine. It also evaluated whether V114 can be administered concomitantly with influenza
      vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to
      the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine
      (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior
      when administered concomitantly as compared with non-concomitant administration as measured
      by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI)
      geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to
      the overall safety database and immunogenicity data for V114 to support initial licensure in
      adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health. Any underlying chronic illness must be documented to be in stable
             condition.

          -  A female participant is eligible to participate if she is not pregnant, not
             breastfeeding, and at least 1 of the following conditions applies: a) not a woman of
             childbearing potential (WOCBP) OR b) a WOCBP who agrees to use 1 of the contraceptive
             methods as defined in the protocol during the treatment period and for at least 6
             weeks after the last dose of study intervention.

        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 before Visit 1
             (Day 1)

          -  Known hypersensitivity to any component of pneumococcal polysaccharide vaccine,
             pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine

          -  Known hypersensitivity to any component of influenza vaccines, including egg protein,
             or following a previous dose of any influenza vaccine.

          -  Known or suspected impairment of immunological function

          -  Experienced Guillain-Barré syndrome within 6 weeks of receiving a previous influenza
             vaccination

          -  Coagulation disorder contraindicating intramuscular vaccinations.

          -  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)

          -  Prior administration of any PCV (e.g., Prevnar 13®) or is expected to receive any
             pneumococcal vaccine during the study outside of the protocol.

          -  Prior administration of PNEUMOVAX®23 ≤12 months before Visit 1 (Note: individuals who
             received PNEUMOVAX®23 >12 months prior to Visit 1 are eligible for this study.)

          -  Previous receipt of influenza vaccine during the 2018/2019 flu season or expected to
             receive any influenza vaccine during the study outside of the protocol

          -  Received systemic corticosteroids (≥20 mg/day prednisone equivalent) for ≥14
             consecutive days and has not completed intervention at least 30 days before study
             entry.

          -  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).

          -  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

          -  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.

          -  Is 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.

          -  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 as assessed by the study
             investigator.

          -  Is or has 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.