COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04955626

Not reported

Not reported

2021-07-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

substudy a inclusion criteria: male or female participants ≥16 years of age at visit 1 (day 1) who participated in c4591001. 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. capable of giving signed informed consent. participants who have received 2 prior doses of 30 µg bnt162b2 19-42 days apart, with the second dose being at least 175 days before visit 1 (day 1).

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. 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. 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, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to covid-19, from 90 days before study intervention administration, or planned receipt throughout the study. prior receipt of any covid-19 vaccine other than bnt162b2. 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. receipt of medications intended to prevent covid-19. prior receipt of more than 2 doses of bnt162b2 30 µg. participation in other studies involving study intervention within 28 days prior to study entry, other than c4591001, and/or within 28 days of confirmed receipt of bnt162b2 within the study. substudy b inclusion criteria: male or female participants 12 to 30 years of age, inclusive, who have received 2 prior doses of 30 µg bnt162b2 19 to 60 days apart, with the second dose being at least at least 4 months (120 days) before visit 1 (day 1) 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 (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. capable of giving signed informed consent.

3

BioNTech SE

12

100

Brazil;Canada;Germany;Israel;South Africa;United States

Healthy volunteers

N/A

16385

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSC - the immune response to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age and a third dose of BNT162b2 30 µg in a randomly selected subset of participants 18 through 55 years of age from study C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only);SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

None

Phase 3

[{"arm_notes": "10 \u00b5g", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 \u00b5g", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "60 \u00b5g", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]