A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Intervention: BNT162b2; BNT162b2.B.1.351
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1574.0
Sex: All
Minimum age: 12 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine; BNT162b2; BNT162B2.1.B.351

Summary:

      This is a Phase 3, randomized, observer-blind study in healthy individuals.

      The primary study will evaluate the safety, tolerability, and immunogenicity of the
      SARS-CoV-2 RNA vaccine candidate (BNT162b2):

        -  As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)

        -  As a 20-microgram dose, administered from 1 of the manufacturing lots

        -  As a 2-dose (separated by 21 days) schedule

        -  In people 12 through 50 years of age

      The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2
      RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):

        -  Each as a 30-microgram dose

        -  Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2

        -  In people 18 through 50 years of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary study: Male or female participants between the ages of 12 and 50 years,
             inclusive, at randomization.

          -  Booster study: Male or female participants between the ages of 18 and 50 years,
             inclusive, at rerandomization.

          -  Participants who are willing and able to comply with all scheduled visits, treatment
             plan, laboratory tests, lifestyle considerations, and other study procedures.

          -  Healthy participants who are determined by medical history, physical examination (if
             required), and clinical judgment of the investigator to be eligible for inclusion in
             the study.

          -  Capable of giving personal signed informed consent/have parent(s)/legal guardian
             capable of giving 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 HIV, HCV, or HBV.

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis) to any component of the study intervention.

          -  Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
             was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
             SARS-CoV-2 NAAT result) 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.

          -  Primary study: Previous vaccination with any coronavirus vaccine.

          -  Booster study: Previous vaccination with any coronavirus vaccine outside of this
             study.

          -  Receipt of medications intended to prevent COVID-19.

          -  Individuals who receive treatment with radiotherapy or 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.

          -  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.

        Additional Exclusion Criteria for the Booster study:

          -  Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness
             within 48 hours before study intervention administration.

          -  Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other
             nonstudy vaccine within 28 days, before or after study intervention administration.

          -  Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized,
             intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.