A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants With Moderate to Severe Asthma (VECTOR)

D5180C00031

This is a Phase 3b, multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of tezepelumab (210 mg subcutaneous \[SC\] every 4 weeks \[Q4W\]) on antibody responses following seasonal quadrivalent influenza virus vaccination in the fall/winter 2021-2022 in the USA.

2021-08-23

2022-03-21

2022-07-18

Completed

Early phase I

70

Inclusion Criteria: * Documented physician-diagnosed asthma for at least 12 months prior to Visit 1. * Morning pre-bronchodilator FEV1 (Forced expiratory volume) of \> 50% predicted normal value at Visit 1 or Visit 2. * Body weight ≥ 40 kg. * For women of childbearing potential, a negative urine pregnancy test is required prior to administration of study intervention at Visit 3. * Must have 'not well-controlled' asthma. Exclusion Criteria: * Clinically important pulmonary disease other than asthma. * Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment. * Life-threatening asthma * History of cancer. * Allergy to eggs, if egg based influenza vaccine will be administered. * History of anaphylaxis to any biologic therapy. * Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack-years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible. * History of alcohol or drug abuse within 12 months prior to the date of informed consent. * Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures during the conduct of the study.

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2023-06-22