Conditions: Healthy Japanese Children Age 7 Years Through 18 Years
Keywords: Efficacy Safety Tolerability MEDI3250 Japanese children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1369
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: MEDI3250 Nasal Spray arm 2: Placebo Nasal spray

Interventions: intervention 1: MEDI3250 intervention 2: Placebo
Intervention descriptions: intervention 1: MEDI3250 intervention 2: Placebo

Protocol document: