UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014865
Receipt number R000017279
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 1 trial)
Date of disclosure of the study information 2014/08/18
Last modified on 2016/01/26 18:42:19

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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 1 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 1 trial)(H7N9BK_P1)

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 1 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 1 trial)(H7N9BK_P1)

Region

Japan


Condition

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate safety profile of the inactivated whole virus vaccine to avian influenza A/H7N9 whose infection to human became clear in March 2013.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety endpoint
Kind, degree and duration of the adverse event and side reaction between the first vaccination and the last evaluation day

Key secondary outcomes

Immunologic endpoint
SRH antibody titer, HI antibody titer and neutralizing antibody titer of avian influenza A/H7N9


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

BK1313 Low Dose Group (5 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.

Interventions/Control_2

BK1313 Middle Dose Group (5 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.

Interventions/Control_3

BK1313 High Dose Group (5 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 twice. After 21 days from first administration, the patients are vaccinated again.

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

40 years-old >=

Gender

Male

Key inclusion criteria

1)Individuals , who have not been vaccinated with influenza A (H7N9)vaccine. (20-40 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 first administration to the last day of follow-up , Individuals , who wish to become pregnant partner, and Individuals , who could not perform the appropriate method of contraception.

9)Individuals , who are deemed to be inappropriate by the investigator.

Target sample size

15


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

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


Email

h7n9-influenza@hosp.go.jp


Sponsor or person

Institute

Clinical Research Center,
National Hospital Organization

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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2014年7月17日、届出回数第1回


Institutions

Institutions

独立行政法人　国立病院機構　東京医療センター（東京都）


Other administrative information

Date of disclosure of the study information

2014 Year 08 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 07 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 18 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

2014 Year 08 Month 14 Day

Last modified on

2016 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017279