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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,369
Research Site
Akashi-shi, Japan
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)
the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)
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Research Site
Chofu-shi, Japan
Research Site
Fuchu-shi, Japan
Research Site
Fujimi-shi, Japan
Research Site
Fukui-shi, Japan
Research Site
Fukuoka, Japan
Research Site
Fukuroi-shi, Japan
Research Site
Funabashi-shi, Japan
Research Site
Gifu, Japan
Research Site
Hatsukaichi-shi, Japan
...and 28 more locations