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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE

NCT04713553•BioNTech SE

View on ClinicalTrials.gov

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

Age

12 - 50 years

Sex

ALL

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.
+8 more criteria

Locations (17)

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

Key Dates

Start Date

February 15, 2021

Primary Completion Date

July 22, 2021

Completion Date

July 22, 2021

Last Updated

December 22, 2022

Enrollment

1,574

ACTUAL participants

Conditions

SARS-CoV-2 InfectionCOVID-19

Interventions

BNT162b2

BIOLOGICAL

BNT162b2.B.1.351

BIOLOGICAL

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

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RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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