COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05543616

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2022-09-16

Recruiting

nonRCT

Non-randomized

Parallel

Blind label

multi-center

Prevention

substudy a inclusion criteria: - healthy male or female participants ≥6 months to <4 years 3 months of age, at the time of randomization.

previous or current diagnosis of multisystem inflammatory syndrome in children (mis-c). history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, or individuals who receive treatment with immunosuppressive therapy. individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. note: stable type 1 diabetes and hypothyroidism are permitted. previous vaccination with any covid-19 vaccine. receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer) or radiotherapy, within 60 days before enrollment through the conclusion of the study. systemic corticosteroids (≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg) for ≥14 days is prohibited from 28 days prior to enrollment through 28 days after administration of study intervention. receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies (except palivizumab), 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. substudy b inclusion criteria: - healthy male or female participants = ≥6 months to <5 years of age, at the time of enrollment.

19

BioNTech SE

0

11

United States

Healthy volunteers

N/A

3020

SSA - Ph 1 dose finding, percentage of participants reporting adverse events;SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events;SSA - Ph 1 dose finding, percentage of participants reporting systemic events;SSA - Ph 2/3 selected dosed, superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSA - Ph 2/3 selected dose, noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age;SSA - Ph 2/3 selected dose, noninferiority with respect to the seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age;SSA - Ph 2/3 selected dose, percentage of participants reporting adverse events;SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions;SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events;SSA - Ph 2/3 selected dose, percentage of participants reporting systemic events;SSA - Ph 2/3 selected dose, superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSB - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age;SSB - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age;SSB - percentage of participants reporting adverse events;SSB - percentage of participants reporting serious adverse events;SSB - percentage of participants reporting systemic events;SSB - Ph 2/3 selected dose, noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age;SSB - Ph 2/3 selected dose, superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSB - ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSB - ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age;SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age;SSC - Ph 1 dose finding, percentage of participants reporting adverse events;SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events;SSC - Ph 1 dose finding, percentage of participants reporting systemic events;SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age;SSC - Ph 2/3 selected dose - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain for participants ≥6 months to <5 years of age;SSC - Ph 2/3 selected dose - percentage of participants reporting adverse events;SSC - Ph 2/3 selected dose, percentage of participants reporting local reactions;SSC - Ph 2/3 selected dose - percentage of participants reporting serious adverse events;SSC - Ph 2/3 selected dose, percentage of participants reporting systemic events;SSC - Ph 2/3 selected dose - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age;SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age;SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain participants ≥5 to <12 years of age;SSD - percentage of participants reporting adverse events;SSD - percentage of participants reporting serious adverse events;SSD - percentage of participants reporting systemic events;SSD - ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age;SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age;Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions;Substudy B (SSB) - percentage of participants reporting local reactions;Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions;Substudy D (SSD) - percentage of participants reporting local reactions

None

Phase 2/Phase 3

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