UMIN-CTR Clinical Trial

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

Prevention of avian influenza

Classification by specialty

Infectious disease

Adult

Classification by malignancy

Others

Genomic information

YES

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Center, National Hospital Organization

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2015

Year

02

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

02

Month

18

Day

Last modified on

2016

Year

02

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019234