Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age
Condition: Respiratory Syncytial Virus
Intervention: RSVpreF Vaccine; Placebo; Seasonal Inactivated Influenza Vaccine
Intervention description: RSV Vaccine; Placebo; SIIV
Intervention MeSH terms: Vaccines
Phase: Phase 3
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: This study is double-blinded.
The participant, study coordinator, and all site staff will be blinded.
The majority of sponsor staff will be blinded to study intervention allocation. All laboratory testing personnel performing serological assays or diagnostic assays will remain blinded to the study intervention assigned/received throughout the study.
Enrollment: 1471.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory tract infection; RSV; vaccine; older adults

Summary:

      The purpose of this study is to assess the safety and immunogenicity of RSVpreF when
      coadministered with SIIV compared to sequential administration of the vaccines when given 1
      month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data
      supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in
      infants through maternal immunization and in older adults through active vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants ≥65 years of age at the time of consent.

          2. Participants who are willing and able to comply with scheduled visits, laboratory
             tests, lifestyle considerations, and other study procedures, including daily
             completion of the e diary for 7 days after each study vaccination.

          3. Healthy participants who are determined by medical history, physical examination and
             clinical judgment of the investigator to be eligible for inclusion in the study.

          4. Capable of giving signed informed consent

        Exclusion Criteria:

          1. Bleeding diathesis or condition associated with prolonged bleeding time that may
             contraindicate IM injection.

          2. History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the study intervention or any related
             vaccine.

          3. Allergy to egg proteins (egg or egg products) or chicken proteins.

          4. History of Guillain-Barré syndrome.

          5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease
             with or without dialysis, clinically unstable cardiac disease, or any other disorder
             that, in the investigator's opinion, excludes the participant from participating in
             the study.

          6. Immunocompromised individuals with known or suspected immunodeficiency, as determined
             by history and/or laboratory/physical examination.

          7. Other medical or psychiatric condition, including recent (within the past year) or
             active suicidal ideation/behavior, or laboratory abnormality that may increase the
             risk of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study.

          8. Previous vaccination with any licensed or investigational RSV vaccine at any time
             prior to enrollment, or planned receipt throughout the study of nonstudy RSV vaccine.

          9. Previous vaccination with any influenza vaccine within 6 months before study
             intervention administration, or planned receipt of any nonstudy licensed or
             investigational influenza vaccine during study participation.

         10. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study
             intervention administration, or planned receipt throughout the study.

         11. Individuals who receive chronic treatment with immunosuppressive therapy, including
             cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy,
             eg, for cancer or an autoimmune disease, from 60 days before study intervention
             administration or planned receipt throughout the study. If systemic corticosteroids
             (<20 mg/day of prednisone or equivalent) have been administered short term (<14 days)
             for treatment of an acute illness, participants should not be enrolled in the study
             until corticosteroid therapy has been discontinued for at least 28 days before study
             intervention administration. Inhaled/nebulized, intra articular, intrabursal, or
             topical (skin or eyes) corticosteroid use is permitted.

         12. Current alcohol abuse or illicit drug use.

         13. Current use of any prohibited concomitant medication(s) or those unwilling/unable to
             use a permitted concomitant medication(s)

         14. Participation in other studies involving investigational product(s) within 28 days
             prior to consent and/or during study participation

         15. Investigator site staff or Pfizer employees directly involved in the conduct of the
             study, site staff otherwise supervised by the investigator, and their respective
             family members