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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.