Unique ID issued by UMIN | UMIN000015814 |
---|---|
Receipt number | R000018399 |
Scientific Title | Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2 trial) |
Date of disclosure of the study information | 2014/12/02 |
Last modified on | 2016/01/26 18:43:27 |
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2 trial)
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2 trial)(H7N9BK_P2)
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2 trial)
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2 trial)(H7N9BK_P2)
Japan |
Prevention of influenza
Infectious disease |
Others
YES
To evaluate immunogenicity profile of the inactivated whole virus vaccine to avian influenza A/H7N9 whose infection to human became clear in March 2013.
Efficacy
Exploratory
Phase II
Immunologic endpoint
SRH antibody titer of avian influenza A/H7N9
Immunologic endpoint
HI antibody titer and neutralizing antibody titer of avian influenza A/H7N9
Interventional
Parallel
Randomized
Double blind -all involved are blinded
Dose comparison
3
Prevention
Vaccine |
BK1313 Middle Dose with adjuvant Group (45 persons per group) is intramuscularly vaccinated with the vaccine containing 7.5microg/dose of hemagglutinin (HA) mixed with aluminum hydroxide (0.15mg).
For this study, each groups are vaccinated twice. After 21 days from first administration, the patients are vaccinated again.
BK1313 High Dose with adjuvant Group (45 persons per group) is intramuscularly vaccinated with the vaccine containing 15microg/dose of hemagglutinin (HA) mixed with aluminum hydroxide (0.15mg).
For this study, each groups are vaccinated twice. After 21 days from first administration, the patients are vaccinated again.
BK1313 High Dose without adjuvant Group (50 persons per group) is intramuscularly vaccinated with the vaccine containing 30microg/dose of hemagglutinin (HA).
For this study, each groups are vaccinated 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 could be consent by document that have been approved by IRB
3)Individuals, who could be follow up survey for five years after inoculation
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.(obtained 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.
150
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
h7n9-influenza@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
h7n9-influenza@hosp.go.jp
Clinical Research Center,
National Hospital Organization
Ministry of Health, Labour and Welfare
NO
初回届出年月日2014年7月17日、届出回数第2回
独立行政法人 国立病院機構 九州医療センター(福岡県)、別府医療センター(大分県)、金沢医療センター(石川県)、千葉東病院(千葉県)、三重中央医療センター(三重県)
NHO Kyusyu medical center,NHO Beppu medical center, NHO Kanazawa medical center, NHO Chiba-East hospital, NHO Mie Chuo medical center
2014 | Year | 12 | Month | 02 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 31 | Day |
2014 | Year | 12 | Month | 11 | Day |
2014 | Year | 12 | Month | 01 | Day |
2016 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018399
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |