Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Intervention: BNT162b2; Placebo
Intervention description: BNT162b2 (intramuscular injection); Placebo (intramuscular injection)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy
      Japanese adults.

      The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA
      vaccine candidate against COVID-19:

        -  As 2 doses, separated by 21 days

        -  At a single dose level

        -  In adults 20 to 85 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female participants between the ages of 20 and 85 years, inclusive,
             at randomization.

          -  Participants who are willing and able to comply with all scheduled visits, vaccination
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          -  Healthy participants who are determined by medical history, physical examination, and
             clinical judgment of the investigator to be eligible for inclusion in the study.

          -  Capable of giving personal signed informed consent.

        Exclusion Criteria:

          -  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.

          -  Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
             hepatitis B virus (HBV).

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the study intervention(s).

          -  Receipt of medications intended to prevent COVID-19.

          -  Previous confirmed diagnosis of COVID-19.

          -  Immunocompromised individuals with known or suspected immunodeficiency, as determined
             by history and/or laboratory/physical examination.

          -  Bleeding diathesis or condition associated with prolonged bleeding that would, in the
             opinion of the investigator, contraindicate intramuscular injection.

          -  Women who are pregnant or breastfeeding.

          -  Previous vaccination with any coronavirus vaccine.

          -  Individuals 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.

          -  Receipt of blood/plasma products or immunoglobulin, from 60 days before study
             intervention administration or planned receipt throughout the study.

          -  Participation in other studies involving study intervention within 28 days prior to
             study entry and/or during study participation.

          -  Previous participation in other studies involving study intervention containing lipid
             nanoparticles.

          -  Subset only: Any screening hematology and/or blood chemistry laboratory value that
             meets the definition of a ≥ Grade 1 abnormality.

          -  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.