UMIN-CTR Clinical Trial

Public title

Safety of the pandemic influenza A(H5N1) vaccination (Kaketsuken) on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza was spread.

Acronym

Safety of the Influenza A(H5N1) vaccination on 1,000 healthy volunteers (H5N1_KD safety)

Scientific Title

Safety of the pandemic influenza A(H5N1) vaccination (Kaketsuken) on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza was spread.

Scientific Title:Acronym

Safety of the Influenza A(H5N1) vaccination on 1,000 healthy volunteers (H5N1_KD safety)

Region

Japan

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of safety of the adjuvanted influenza A(H5N1) vaccine of Vietnam strain or Indonesia strain, This vaccine was approved by MHLW in 2011 as the 3rd vaccine in the domestic manufacturers, Effectiveness of the vaccine might be evaluated based on the incidence of influenza like illness, when H5N1 type influenza is spread within five years.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Survey for safety after adjuvanted influenza A (H5N1) vaccine

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Inclusion criteria
1)Individuals , who have not been vaccinated with influenza A (H5N1) vaccine

2)Individuals,who could be follow up survey for five years after inoculation

3)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 Swine Influenza A (H5N1) 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)Individuals who are deemed to be inappropriate by the investigator

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Toshiaki Ihara

Organization

National Hospital Organization Mie National Hospital

Division name

Director

Zip code

Address

357 Ozato-Kubota, Tsu, Mie

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Clinical Research Center, National Hospital Organization

Division name

Clinical trial promotion office,

Zip code

Address

TEL

Homepage URL

Email

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

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

Institutions

Date of disclosure of the study information

2012

Year

01

Month

10

Day

URL releasing protocol

Publication of results

Published

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

Main results already published

Date of protocol fixation

2011

Year

12

Month

06

Day

Date of IRB

Anticipated trial start date

2011

Year

12

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

prospective observational study

Registered date

2012

Year

01

Month

06

Day

Last modified on

2016

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008295