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

Purpose

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

Conditions

  • SARS-CoV-2 Infection
  • COVID-19

Eligibility

Eligible Ages
Between 12 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 		30-microgram dose of US manufactured drug substance (Lot 1)
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Arm 2 		30-microgram dose of US manufactured drug substance (Lot 2)
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Arm 3 		30-microgram dose of US manufactured drug substance (Lot 3)
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Arm 4 		30-microgram dose of EU manufactured drug substance (Lot 4)
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Arm 5 		20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Booster 1: BNT162b2 		30-microgram dose
  • Biological: BNT162b2
    Intramuscular injection
Experimental
Booster 2: BNT162b2.B.1.351 		30-microgram dose
  • Biological: BNT162b2.B.1.351
    Intramuscular injection

Recruiting Locations

More Details

NCT ID
NCT04713553
Status
Completed
Sponsor
BioNTech SE