Unique ID issued by UMIN | UMIN000016577 |
---|---|
Receipt number | R000019234 |
Scientific Title | To investigate efficacy and safety of KD-295-H7N9 |
Date of disclosure of the study information | 2015/02/18 |
Last modified on | 2016/02/23 18:44:12 |
To investigate efficacy and safety of KD-295-H7N9
To investigate efficacy and safety of KD-295-H7N9(H7N9-KD-P12)
To investigate efficacy and safety of KD-295-H7N9
To investigate efficacy and safety of KD-295-H7N9(H7N9-KD-P12)
Japan |
Prevention of avian influenza
Infectious disease | Adult |
Others
YES
To evaluate immunogenicity profile of KD-295-H7N9 to avian influenza A/H7N9 whose infection to human became clear in March 2013.
Safety,Efficacy
Exploratory
Phase I,II
Immunologic endpoint
HI antibody titer of avian influenza A/H7N9
Immunologic endpoint
neutralizing antibody titer of avian influenza A/H7N9
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Vaccine |
Subjects are administered KD-295-H7N9 intramuscularly twice. After 21 days from first administration, the patients are vaccinated again.
20 | years-old | <= |
Not applicable |
Male and Female
1)Individuals, who have not been vaccinated with influenza A (H7N9) vaccine (over 20 years old).
2)Individuals who consent to the study by documents that have been approved by IRB.
3)Individuals, in case avian influenza A/H7N9 outbreak comes within five years after inoculation, who agreed to join the follow-up survey.
4)Individuals who could keep the compliance with this study's rules.
5)Individuals, who could be followed under the regulation of the clinical trial, could be examined according to the protocol, and could report their symptoms.
1)Individuals with the history of Avian Influenza A (H7) virus infection. (hearing from subjects)
2)Individuals, who had history of anaphylaxis to foods or medicines previously.
3)Individuals with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
4)Individuals with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
5)Individuals participated in a clinical trial within four months (counted from the date of vaccination).
6)Individuals vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (including the day of vaccination).
7)Individuals received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg/kg or more) within six months (including the day of vaccination).
8)From the day of the first administration to the last day of follow-up, Individuals or partners, who wish to become pregnant , and Individuals , who could not perform the appropriate method of contraception.
9)A breast-feeding women, a pregnant women or a suspected pregnancy woman
10)Individuals, who are deemed to be inappropriate by the investigator.
50
1st name | |
Middle name | |
Last name | Suminobu Ito |
Clinical Research Center, National Hospital Organization
Clinical Research Division
2-5-21 Higashigaoka,Meguro-ku,Tokyo
03-5712-5087
h7n9vaccine@hosp.go.jp
1st name | |
Middle name | |
Last name | Suminobu Ito |
Clinical Research Center, National Hospital Organization
Clinical Research Division
2-5-21 Higashigaoka,Meguro-ku,Tokyo
03-5712-5087
h7n9vaccine@hosp.go.jp
Clinical Research Center, National Hospital Organization
Ministry of Health, Labour and Welfare
Japan
NO
初回届出年月日2015年1月19日 届出回数第1回
2015 | Year | 02 | Month | 18 | Day |
Unpublished
Completed
2014 | Year | 12 | Month | 24 | Day |
2015 | Year | 02 | Month | 23 | Day |
2015 | Year | 02 | Month | 18 | Day |
2016 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019234
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |