A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity ofMultiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
- Conditions
- SARS-CoV-2 InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-005903-11-Outside-EU/EEA
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 445
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1128
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method