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

Conditions: SARS-CoV-2 Infection; COVID-19

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 criteria:
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. * 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.

Keywords: covid-19 coronavirus vaccine sars-cov-2 rna vaccine bnt162b2 bnt162b2.1.b.351