A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Intervention: BNT162b2
Intervention description: Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 629.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine

Summary:

      This study will compare the safety and tolerability of lyophilized BNT162b2 presented in
      single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether
      the immune response is noninferior. Separately, the study will also describe the safety and
      immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of
      specification and ready to use BNT162b2 (the immediate manufacturing precursor to the
      lyophilate). Additionally, the study will describe the safety and immunogenicity of an
      additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose
      schedule of lyophilized BNT162b2.

        -  2-dose schedule (separated by 21 days)

        -  At a dose of 30µg (as studied in the Phase 2/3 study C4591001)

        -  In healthy adults 18 through 55 years of age

        -  The duration of the study for each participant will be approximately 2 months (3 visits
           in total)

        -  The study will be conducted in the United States
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).

          -  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. Note: Healthy participants with pre-existing stable disease, defined as
             disease not requiring significant change in therapy or hospitalization for worsening
             disease during the 6 weeks before enrolment, can be included.

          -  Capable of giving personal signed informed consent, which includes compliance with the
             requirements and restrictions listed in the ICD and in the protocol.

          -  For Dose 3: Participants who received BOTH doses of the lyophilized formulation of
             BNT162b2 as part of the initial study.

        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(s).

          -  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.

          -  Previous vaccination with any coronavirus vaccine.

          -  Receipt of medications intended to prevent COVID-19.

          -  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 cancer or an autoimmune disease, or planned receipt throughout the study.
             Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
             corticosteroids are permitted.

          -  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 (LNPs).

          -  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.