Healthy Japanese Children Age 7 Years Through 18 Years Clinical Trial
Official title:
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children Age 7 Years Through 18 Years
The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.
This randomized, double-blind, placebo controlled, multicenter study will enrol 1008
subjects. The study is designed to gather the efficacy, safety and tolerability data in
Japanese children 7 through 18 years of age that would support approval of MEDI3250 in
Japan.
For children age 7 years through 18 years, the recommended dosage schedule for intranasal
administration is 0.2 mL (0.1 mL per nostril). For children age 7 years through 8 years not
previously vaccinated against seasonal influenza, a second dose should be given after an
interval of at least 4 weeks.
For the efficacy endpoint, data will be gathered on the incidence of laboratory-confirmed
influenza-like illness in the two treatment arms. Laboratory-confirmed influenza-like
illness would include cases of influenza diagnosed using culture-confirmation and/or
PCR-based methods.
For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs
and SAEs.
Subject will be randomized 2:1 to receive MEDI3250 or placebo.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention