UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023732 |
|---|---|
| Receipt number | R000026898 |
| 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 2b trial) |
| Date of disclosure of the study information | 2016/08/23 |
| Last modified on | 2017/01/10 19:38:50 |
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Basic information
Public title
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2b trial)
Acronym
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2b trial)(H7N9BK_P2b)
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 2b trial)
Scientific Title:Acronym
Efficacy and safety of the avian influenza A/H7N9 inactivated whole-virus vaccine produced using the embryonated egg in human (Investigator-initiated Phase 2b trial)(H7N9BK_P2b)
Region
| Japan |
Condition
Condition
Prevention of influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate immunogenicity profile of the inactivated whole virus vaccine to avian influenza A/H7N9 whose infection to human became clear in March 2013.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Immunologic endpoint
SRH antibody titer of avian influenza A/H7N9
Key secondary outcomes
Immunologic endpoint
HI antibody titer and neutralizing antibody titer of avian influenza A/H7N9
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
BK1313 High Dose with adjuvant Group (50 persons per group) is intramuscularly vaccinated with the vaccine containing 30microg/dose of hemagglutinin (HA) mixed with aluminum hydroxide (0.15mg).
For this study, each groups are vaccinated three times. After 21 days and 81days from first administration, the patients are vaccinated again.
Interventions/Control_2
BK1313 Super High Dose with adjuvant Group (55 persons per group) is intramuscularly vaccinated with the vaccine containing 45microg/dose of hemagglutinin (HA) mixed with aluminum hydroxide (0.15mg).
For this study, each groups are vaccinated three times. After 21 days from first administration, the patients are vaccinated again.After 81days from first administration, the patients receive placebo in this group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suminobu Ito |
Organization
Clinical Research Center, National Hospital Organization
Division name
Clinical Research Division
Zip code
Address
2-5-21 Higashigaoka,Meguro-ku,Tokyo
TEL
03-5712-5087
h7n9-influenza@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suminobu Ito |
Organization
Clinical Research Center, National Hospital Organization
Division name
Clinical Research Division
Zip code
Address
2-5-21 Higashigaoka,Meguro-ku,Tokyo
TEL
03-5712-5087
Homepage URL
h7n9-influenza@hosp.go.jp
Sponsor or person
Institute
Clinical Research Center,
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026898
