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

Completed · Phase 3

Conditions studied: SARS-CoV-2 Infection, COVID-19

In brief

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

Key facts

Study ID

NCT04713553

Run by

BioNTech SE

People needed

1574

Starts

2021-02-15

Expected to finish

2021-07-22

Last updated by the study team

2022-12-22

Who can join

Age: 12 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente Oakland — Oakland, California, United States
• Clinical Research Consulting — Milford, Connecticut, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• Research Centers of America — Hollywood, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Amici Clinical Research LLC — Raritan, New Jersey, United States
• Accellacare - Wilmington — Wilmington, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Texas Center for Drug Development, Inc. — Houston, Texas, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States
• Martin Diagnostic Clinic — Tomball, Texas, United States
• J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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