JRCT ID: jRCT2080221313
Registered date:17/11/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Prophylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection. |
Date of first enrollment | 17/11/2010 |
Target sample size | 374 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : DD-687 INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Subcutaneous injection control material(s) Generic name etc : DTaP, Oral Polio Vaccine INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Subcutaneous injection, Oral |
Outcome(s)
Primary Outcome | Immunogenicity anti-Polio 1, 2 and 3 antibody titers |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | starting at 3-68 (recommended 3-8) months of age |
Exclude criteria |
Related Information
Primary Sponsor | DAIICHISANKYO Co.,Ltd., Sanofi Aventis KK |
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Secondary Sponsor | The Kitasato Institute, Sanofi Pasteur KK, Sanofi Pasteur SA |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101350 |
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 |