Status:
COMPLETED
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
Lead Sponsor:
BioNTech SE
Collaborating Sponsors:
Pfizer
Conditions:
SARS-CoV-2 Infection
COVID-19
Eligibility:
All Genders
12-50 years
Phase:
PHASE3
Brief 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 (BNT16...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2021
Estimated Enrollment :
1574 Patients enrolled
Trial Details
Trial ID
NCT04713553
Start Date
February 15 2021
End Date
July 22 2021
Last Update
December 22 2022
Active Locations (17)
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1
Kaiser Permanente Oakland
Oakland, California, United States, 94611
2
Clinical Research Consulting
Milford, Connecticut, United States, 06460
3
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
4
Research Centers of America
Hollywood, Florida, United States, 33024