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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016577
Receipt No. 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

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Basic information
Public title To investigate efficacy and safety of KD-295-H7N9
Acronym To investigate efficacy and safety of KD-295-H7N9(H7N9-KD-P12)
Scientific Title To investigate efficacy and safety of KD-295-H7N9
Scientific Title:Acronym To investigate efficacy and safety of KD-295-H7N9(H7N9-KD-P12)
Region
Japan

Condition
Condition Prevention of avian influenza
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate immunogenicity profile of KD-295-H7N9 to avian influenza A/H7N9 whose infection to human became clear in March 2013.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Immunologic endpoint
HI antibody titer of avian influenza A/H7N9
Key secondary outcomes Immunologic endpoint
neutralizing antibody titer of avian influenza A/H7N9

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Subjects are administered KD-295-H7N9 intramuscularly twice. After 21 days from first administration, the patients are vaccinated again.
Interventions/Control_2
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 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.
Key exclusion criteria 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.
Target sample size 50

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
Email h7n9vaccine@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
Email h7n9vaccine@hosp.go.jp

Sponsor
Institute Clinical Research Center, National Hospital Organization
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW 初回届出年月日2015年1月19日 届出回数第1回

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 18 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 Completed
Date of protocol fixation
2014 Year 12 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 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
2015 Year 02 Month 18 Day
Last modified on
2016 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.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


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