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
NCT ID: NCT04713553
Last Updated: 2022-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1574 participants
INTERVENTIONAL
2021-02-15
2021-07-22
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Arm 1
30-microgram dose of US manufactured drug substance (Lot 1)
BNT162b2
Intramuscular injection
Arm 2
30-microgram dose of US manufactured drug substance (Lot 2)
BNT162b2
Intramuscular injection
Arm 3
30-microgram dose of US manufactured drug substance (Lot 3)
BNT162b2
Intramuscular injection
Arm 4
30-microgram dose of EU manufactured drug substance (Lot 4)
BNT162b2
Intramuscular injection
Arm 5
20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)
BNT162b2
Intramuscular injection
Booster 1: BNT162b2
30-microgram dose
BNT162b2
Intramuscular injection
Booster 2: BNT162b2.B.1.351
30-microgram dose
BNT162b2.B.1.351
Intramuscular injection
Interventions
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BNT162b2
Intramuscular injection
BNT162b2.B.1.351
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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.
12 Years
50 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4591017
Identifier Type: -
Identifier Source: org_study_id