♦Basic information
JapicCTI-No. JapicCTI-142493
♦Title of the study
Title of the study A randomized, double-blind, confirmatory study of VN-100 in healthy elderly volunteers
Public title of the study VN-100 Ph3 non-inferiority study
Primary sponsor DAIICHISANKYO Co.,Ltd.
Secondary sponsor TERUMO CORPORATION
Secondary sponsor KITASATO DAIICHI SANKYO VACCINE COMPANY, LIMITED
Secondary sponsor JAPAN VACCINE COMPANY, LIMITED
Study Type interventional (vaccine)
Summary To demonstrate the immunological non-inferiority of VN-100 versus subcutaneously administered influenza HA vaccine in healthy elderly volunteers
♦Details of the study
Disease or condition Prophylaxis of influenza infection
Intervention
Intervention name VN-100
Classification name(code) of the intervention 631 (vaccines)
Dosage And administration of the intervention Intradermal
Control intervention name(code)/td> Influenza HA vaccine
Classification name(code) of the control intervention 631 (vaccines)
Dosage And administration of the control intervention Subcutaneous
Objectives of the study Prophylaxis
Study phase Phase 3
Study design A multicenter, randomized, active control, double blind, parallel-group study
Target sample size 900
Inclusion Criteria Healthy elderly Japanese volunteers

AgeF     65years old or more
SexF     Both
Exclusion Criteria 1) Subjects with history of seasonal influenza in the past 6 months
2) Subjects with history of seasonal influenza vaccination in the past 6 months

Outcome
Primary Outcome The difference between the seroconversion rates and the ratio of GMTs of HI antibody titer against three vaccine stains at Day 21
Timepoints To demonstrate the immunological non-inferiority in terms of the difference between the seroconversion rates (VN-100 seasonalinfluenza vaccine) and the ratio of GMTs (VN-100/seasonal influenza vaccine) of HI antibody titer against three vaccine stains at Day 21. The criteria are as follows.
1)The lower bound of the two-sided 95% CI on the difference between the seroconversion rates exceed -10 percentage points.
2)The lower bound of the two-sided 95% CI on the ratio of the GMTs exceed 2/3.
In case the non-inferiority is actually demonstrated, the following criteria regarding superiority are evaluated collaterally.
Secondary Outcome Seroconversion rate, GMTs, and Seroprotection rate of HI antibody titer against three vaccine stains
Timepoints
Institutions
Duration of the study 2014-3-25  `  2014-8-31
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/corporate/rd/measure/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
2015/1/15   revised
2014/5/28   revised
2014/3/31   revised
2014/3/28   application date