NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Prophylaxis of influenza infection
Date of first enrollment	11/10/2016
Target sample size	782
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MEDI3250 INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intranasal administration was 0.1 mL per nostril.(total 0.2mL) control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Intranasal administration was 0.1 mL per nostril.(total 0.2mL)

Outcome(s)

Primary Outcome

1)Efficacy The incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains regardless of match to the vaccine. 2) Safety Incidence of treatment-emergent adverse events -Solicited adverse events for 14 days post vaccination -Adverse events for 28 days post vaccination -Serious adverse events from informed consent until the end of the study. The endpoint is evaluated by constructing a 2-sided 95% exact confidence interval for the risk reduction of MEDI3250 compared to placebo.

Secondary Outcome

The incidence of wild type influenza infection from the genotyping test, caused by vaccine-matched strain in the influenza surveillance period. The endpoint is evaluated by constructing a 2-sided 95% exact confidence interval for the risk reduction of MEDI3250 compared to placebo.

Key inclusion & exclusion criteria

Age minimum	>= 2age old
Age maximum	<= 18age old
Gender	Both
Include criteria	1) Healthy Japanese Children age 2 years through 18 years at the time of informed consent. 2) The ability of the subject to give to comply with study procedures and performed any study-specific procedure, to offer any symptom.
Exclude criteria	1) Administration of any influenza virus vaccine within 6 months prior to informed consent. 2) Use of antiviral agents with activity against influenza virus within 28 days prior to informed consent.