Conditions: Healthy Japanese Children Age 2 Years Through 6 Years
Keywords: Safety Tolerability MEDI3250 Japanese children
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

Brief summary:
This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan.

Detailed description:
For children age 2 years through 6 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Arms:
arm 1: MEDI3250 Nasal spray

Interventions: intervention 1: MEDI3250
Intervention descriptions: intervention 1: MEDI3250

Protocol document: