A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
NCT ID: NCT04816669
Last Updated: 2022-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2021-04-01
2021-12-02
Brief Summary
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* 2-dose schedule (separated by 21 days)
* At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
* In healthy adults 18 through 55 years of age
* The duration of the study for each participant will be approximately 2 months (3 visits in total)
* The study will be conducted in the United States
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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Lyophilized SDV
BNT162b2
Intramuscular injection
Frozen liquid MDV (control for lyo SDV)
Control for lyophilized SDV
BNT162b2
Intramuscular injection
Frozen-liquid with LNP size at the upper end of specification
BNT162b2
Intramuscular injection
RTU
BNT162b2
Intramuscular injection
Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)
Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2
BNT162b2
Intramuscular injection
Interventions
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BNT162b2
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.
* Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
* For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.
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(s).
* 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.
* Previous vaccination with any coronavirus vaccine.
* Receipt of medications intended to prevent COVID-19.
* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
* 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 (LNPs).
* 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.
18 Years
55 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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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, 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
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Amici Clinical Research LLC
Raritan, New Jersey, United States
Accellacare (formerly PMG Research of Wilmington, LLC)
Wilmington, North Carolina, United States
Aventiv Research Inc
Columbus, Ohio, United States
Benchmark Research
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
DM Clinical Research (Administrative and Storage Office only)
Tomball, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 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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C4591020
Identifier Type: -
Identifier Source: org_study_id