A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
Condition: Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Intervention: Formulation A; Formulation B; Formulation C; Placebo
Intervention description: RSV vaccine; Adjuvanted RSV vaccine; RSV vaccine; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Observer blind
Enrollment: 317.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory tract infection, RSV, Adjuvant, vaccine

Summary:

      The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV
      vaccine candidates, some with adjuvant, when administered concomitantly with seasonal
      inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine
      administered12 months after the initial dose.

      In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Evidence of a personally signed and dated informed consent document (ICD) indicating
             that the subject has been informed of all pertinent aspects of the study.

          2. Healthy adults who are determined by medical history, physical examination, and
             clinical judgment of the investigator to be eligible for inclusion in the study.

          3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests,
             and other study procedures.

          4. Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of
             enrollment (signing of the ICD).

          5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit
             1 and have signed and dated the ICD for participating in the revaccination stage
             (applies to Primary Study Cohort - Stage 2 subjects).

        Exclusion Criteria:

          1. Investigator site staff members directly involved in the conduct of the study and
             their family members, site staff members otherwise supervised by the investigator, or
             subjects who are Pfizer employees, including their family members, directly involved
             in the conduct of the study.

          2. Participation in other studies involving investigational product within 28 days prior
             to study entry and/or during study participation.

          3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).

          4. Previous vaccination with any licensed or investigational RSV vaccine before
             enrollment into the study, or planned receipt throughout the study of nonstudy RSV
             vaccine.

          5. Vaccination with any influenza vaccine within 6 months (182 days) before
             investigational product administration (applies to Primary Study Cohort - Stages 1 and
             2).

          6. History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the investigational product(s),
             including natural rubber latex. In addition, a history of severe allergic reaction
             (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg
             or egg products) or chicken proteins.

          7. Subjects with known or suspected immunodeficiency, as determined by history and/or
             laboratory/physical examination.

          8. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic
             agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
             planned receipt throughout the study. If systemic corticosteroids have been
             administered short term (<14 days) for treatment of an acute illness, subjects should
             not be enrolled into the study until corticosteroid therapy has been discontinued for
             at least 28 days before investigational product administration.Inhaled/nebulized,
             intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are
             permitted.

          9. Subject with a history of autoimmune disease or an active autoimmune disease requiring
             therapeutic intervention including but not limited to: systemic or cutaneous lupus
             erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré
             syndrome,multiple sclerosis, Sjögren syndrome, idiopathic thrombocytopenic purpura,
             autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal
             arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).

         10. Receipt of blood/plasma products or immunoglobulin, from 60 days before
             investigational product administration or planned receipt throughout the study.

         11. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
             opinion of the investigator, contraindicate intramuscular injection.

         12. Female subjects of childbearing potential or who are pregnant or breastfeeding;
             fertile male subjects who are unwilling to use a highly effective method of
             contraception for at least 28 days after the last dose of investigational product.

         13. Other acute or chronic medical or psychiatric condition including recent (within the
             past year) or active suicidal ideation or behavior or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study.

         14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after
             Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).