JPRN-jRCT2080223345
Unknown
Phase 3
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
Overview
- Phase
- Phase 3
- Sponsor
- DAIICHI SANKYO CO., LTD.
- Enrollment
- 914
Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 2age old to <= 18age old (—)
- Sex
- All
Inclusion 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.
Exclusion 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.
Investigators
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