JRCT ID: jRCT2080222503
Registered date:29/05/2014
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Prophylaxis of new type of influenza infection |
Date of first enrollment | 29/05/2014 |
Target sample size | 150 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : KIB-PCI (H5N1 influenza vaccin) INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intramuscular |
Outcome(s)
Primary Outcome | SRH antibody titer |
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Secondary Outcome | Neutralizing antibody titer |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | <= 19age old |
Gender | Both |
Include criteria | Healthy Japanese children |
Exclude criteria | 1) Subjects with history of H5N1 influenza 2) Subjects with history of H5N1 influenza vaccination |
Related Information
Primary Sponsor | DAIICHISANKYO Co.,Ltd. |
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Secondary Sponsor | KITASATO DAIICHI SANKYO VACCINE COMPANY, LIMITED |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-142554 |
Contact
Public contact | |
Name | |
Address | http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html |
Telephone | |
Affiliation | DAIICHI SANKYO Co.,Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |