♦Basic information
JapicCTI-No. JapicCTI-132190
♦Title of the study
Title of the study Exploratory clinical trial of KIB-PCI in healthy Japanese children
Public title of the study
Primary sponsor DAIICHISANKYO Co.,Ltd.
Secondary sponsor KITASATO DAIICHI SANKYO VACCINE COMPANY, LIMITED
Study Type interventional (vaccine)
Summary To examine the safety and immunogenicity of KIB-PCI in healthy Japanese children
♦Details of the study
Disease or condition Prophylaxis of new type of influenza infection
Intervention
Intervention name KIB-PCI
Classification name(code) of the intervention 631 (vaccines)
Dosage And administration of the intervention intramuscular
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study Prophylaxis
Study phase Phase 2
Study design Single-center, uncontrolled, open-label study
Target sample size 30
Inclusion Criteria 1) healthy Japanese children

SexF     Both
Exclusion Criteria 1) Subjects with history of H5N1 influenza
2) Subjects with history of H5N1 influenza vaccination


Outcome
Primary Outcome SRH antibody titer
Timepoints
Secondary Outcome HI antibody titer
Neutralizing antibody titer
Timepoints
Institutions
Duration of the study 2013-7-16  `  2013-10-31
Study status Finished
recruitment status Study Completed
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization DAIICHISANKYO Co.,Ltd.
Division Contact for Clinical Trial Information
Contact person or e-mail address etc. http://www.daiichisankyo.co.jp/contact/clinical/index.html
Organization@(Scientific)
Division@(Scientific)
Contact person or e-mail address etc.@(Scientific)
♦Other
Source funded
Name of research funds
Other
♦History
History
2014/1/27   revised
2013/10/21   revised
2013/7/16   application date