Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Intervention: BNT162b2; Placebo; Seasonal Inactivated Influenza Vaccine
Intervention description: Intramuscular injection; Saline intramuscular injection; SIIV intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This is an Observer-Blind Study. The vaccines and placebo will be administered by an unblinded third-party site staff member.
Enrollment: 1134.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine

Summary:

      This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2
      when coadministered with SIIV compared to separate administration of the vaccines when given
      1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of
      30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1).

        -  Healthy adults 18 through 64 years of age will be randomized 1:1 to either the
           co-administration group, or the separate administration group

        -  The duration of the study for each participant will be approximately 2 months

        -  There are 3 scheduled study visits each about 1 month apart

        -  The study will be conducted in New Zealand and Australia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants 18 through 64 years of age, inclusive, at the time of consent.

          2. Are willing and able to comply with all scheduled visits, treatment plan, laboratory
             tests, lifestyle considerations, and other study procedures.

          3. Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of study intervention.

          4. Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90
             days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be
             obtained prior to randomization.

          5. Capable of giving personal signed informed consent, which includes compliance with the
             requirements and restrictions listed in the ICD and in this protocol.

        Exclusion Criteria:

          1. 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.

          2. Allergy to egg proteins (egg or egg products) or chicken proteins.

          3. History of Guillain-Barré syndrome.

          4. History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the study intervention(s).

          5. A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28
             days of Visit 1 (Day 1).

          6. Immunocompromised individuals with known or suspected immunodeficiency, as determined
             by history and/or laboratory/physical examination.

          7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
             opinion of the investigator, contraindicate intramuscular injection.

          8. Women who are pregnant or breastfeeding.

          9. Vaccination with any influenza vaccine <6 months before study intervention
             administration, or planned receipt of any licensed or investigational nonstudy
             influenza vaccine during study participation.

         10. Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
             including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
             are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent),
             eg, for COPD, or planned receipt throughout the study. Inhaled/nebulized,
             intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

         11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study
             intervention administration or planned receipt throughout the study.

         12. Receipt of any passive antibody therapy specific to COVID-19 from 90 days before study
             intervention administration or planned receipt throughout the study.

         13. Prior receipt of any COVID-19 vaccine other than BNT162b2 or receipt of more than 3
             prior doses of BNT162b2.

         14. Participation in other studies involving study intervention within 28 days prior to
             study entry and/or during study participation.

         15. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
             of the study, site staff otherwise supervised by the investigator, and their
             respective family members.