A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Intervention: Formulation A; Formulation B; Placebo
Intervention description: 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: 1235.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory tract infections, RSV, vaccine

Summary:

      The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine
      formulations when administered alone or concomitantly with seasonal inactivated influenza
      vaccine (SIIV).
    

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 subject who is able to father children and willing to use a highly effective
             method of contraception as outlined in this protocol until at least 28 days after the
             last dose of investigational product; female subject who is of childbearing potential
             and at risk for pregnancy and who is willing to use a highly effective method of
             contraception as outlined in this protocol until at least 28 days after the last dose
             of investigational product; male subject not able to father children; female subject
             not of childbearing potential.

          5. Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time
             of enrollment (signing of the ICD).

          6. Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65
             to 85 years at the time of enrollment (signing of the ICD).

        Exclusion Criteria:

          1. Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry
             laboratory value that meets the definition of a ≥ Grade 1 abnormality.

          2. Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV),
             hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or
             hepatitis C virus antibodies (HCV Abs) at the screening visit.

          3. 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.

          4. Participation in other studies involving investigational product within 28 days prior
             to study entry and/or during study participation.

          5. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).

          6. Previous vaccination with any licensed or investigational RSV vaccine, or planned
             receipt throughout the study of nonstudy RSV vaccine.

          7. History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the investigational product(s).

          8. Immunocompromised subjects with known or suspected immunodeficiency, as determined by
             history and/or laboratory/physical examination.

          9. 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. Intra-articular,
             intrabursal, or topical (skin or eyes) corticosteroids are permitted.

         10. 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's syndrome, idiopathic thrombocytopenia purpura,
             glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis),
             psoriasis, and insulin-dependent diabetes mellitus (type 1).

         11. Receipt of blood/plasma products or immunoglobulin, from 60 days before
             investigational product administration or planned receipt throughout the study.

         12. 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.

         13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
             opinion of the investigator, contraindicate intramuscular injection.

         14. Women who are pregnant or breastfeeding.

         15. Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months
             (182 days) before investigational product administration.

         16. Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or
             chicken proteins.