A Phase 3, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children age 2 years through 18 years
- Conditions
- Prophylaxis of influenza infection
- Registration Number
- JPRN-jRCT2080223345
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
The incidence of symptoms of influenza infection and onset of influenza identified by testing to be due to any wild-type influenza virus regardless of antigen matching with vaccine strain was 25.5% (152/597) in the MEDI3250 group and 35.9% (104/290) in the placebo group. The relative risk reduction (95% CI) versus the placebo group was 28.8% (12.5-42.0), verifying the superiority of single vaccination with MEDI3250 over placebo in terms of preventing influenza onset in children 2 to <19 years old.
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 914
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method