UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)(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	Suminobu Ito
Organization	Clinical Research Center, National Hospital Organization
Division name	Clinical Research Division
Address	2-5-21 Higashigaoka,Meguro-ku,Tokyo
TEL	03-5712-5087
Email	h7n9-influenza@hosp.go.jp

Public contact
Name of contact person	Suminobu Ito
Organization	Clinical Research Center, National Hospital Organization
Division name	Clinical Research Division
Address	2-5-21 Higashigaoka,Meguro-ku,Tokyo
TEL	03-5712-5087
Homepage URL
Email	h7n9-influenza@hosp.go.jp

Sponsor
Institute	Clinical Research Center, National Hospital Organization
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026898