COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04368728

Not reported

Not reported

2020-04-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: • male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). for the boostability and protection-against-vocs subset: existing participants enrolled to receive a third dose of bnt162b2 at 30 µg or bnt162b2sa; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization. newly enrolled participants enrolled to receive 2 doses of bnt162b2sa; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment. existing participants enrolled to receive a third dose of bnt162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. note that participants <18 years of age cannot be enrolled in the eu. - participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. - healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. - participants who, in the judgment of the investigator, are at risk for acquiring covid-19. - boostability and protection-against-vocs existing participant subset only: participants who provided a serum sample at visit 3, with visit 3 occurring within the protocol-specified window. - capable of giving personal signed informed consent

- 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. - phases 1 and 2 only: known infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b virus (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). - receipt of medications intended to prevent covid 19. - 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 - phase 1 only: individuals at high risk for severe covid-19, including those with any of the following risk factors: - hypertension - diabetes mellitus - chronic pulmonary disease - asthma - current vaping or smoking - history of chronic smoking within the prior year - bmi >30 kg/m2 - anticipating the need for immunosuppressive treatment within the next 6 months - phase 1 only: individuals currently working in occupations with high risk of exposure to sars-cov-2 (eg, healthcare worker, emergency response personnel). - immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. - phase 1 only: individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. - 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. - individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. - phase 1 only: regular receipt of inhaled/nebulized corticosteroids. - 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 through and including 6 months after the last dose of study intervention, with the exception of non-pfizer interventional studies for prevention of covid 19, which are prohibited throughout study participation. - previous participation in other studies involving study intervention containing lipid nanoparticles. - phase 1 only: positive serological test for sars-cov-2 igm and/or igg antibodies at the screening visit. - phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ grade 1 abnormality. - phase 1 only: positive test for hiv, hepatitis b surface antigen (hbsag), hepatitis b core antibodies (hbc abs), or hepatitis c virus antibodies (hcv abs) at the screening visit. - phase 1 only: sars-cov-2 naat-positive nasal swab within 24 hours before receipt of study intervention. - investigator site staff or pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

14

BioNTech SE

12

85

Argentina;Brazil;Germany;South Africa;Turkey;United States

Healthy volunteers

N/A

47079

Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination;Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination;In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions;In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events;In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions;In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events;In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events;In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events;In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events;In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions;In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events;In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting systemic events;In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events;In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions;In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events;In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events;In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events;In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions;In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events;In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events;Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals;Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2;Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals;Percentage of participants 12-15 years of age in Phase 3 reporting adverse events;Percentage of participants 12-15 years of age in Phase 3 reporting adverse events;Percentage of participants in Phase 1 reporting adverse events;Percentage of participants in Phase 1 reporting local reactions;Percentage of participants in Phase 1 reporting serious adverse events;Percentage of participants in Phase 1 reporting systemic events;Percentage of participants in Phase 2/3 reporting adverse events;Percentage of participants in Phase 2/3 reporting serious adverse events;Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values;Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values;Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values;Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments;Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments;Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments

None

Phase 2/Phase 3

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