UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011816
Receipt number R000013799
Scientific Title Safety of the pandemic influenza A (H5N1) vaccination of Egyptian stain on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza might be spread.
Date of disclosure of the study information 2013/09/19
Last modified on 2016/02/24 11:04:36

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Basic information

Public title

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

Acronym

Safety of the Influenza A (H5N1) vaccination on 1,000 healthy volunteers (H5N1_Egypt safety)

Scientific Title

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

Scientific Title:Acronym

Safety of the Influenza A (H5N1) vaccination on 1,000 healthy volunteers (H5N1_Egypt safety)

Region

Japan


Condition

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of safety of the adjuvanted influenza A (H5N1) vaccine of Egyptian strain, this stain epidemic was in 2010. 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



Assessment

Primary outcomes

Survey for safety from first administration influenza A (H5N1) vaccine to last administration influenza A (H5N1) vaccine after 28days.

Key secondary outcomes

Effectiveness of the vaccine might be evaluated based on the incidence of influenza like illness, when H5N1 type influenza is spread within five years.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



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 (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 Avian 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


Research contact person

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

059-232-2531

Email

ihara@mie-m.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 trial promotion office, Clinical Research Department

Zip code


Address

2-5-23 Higashigaoka,Meguro-ku,Toukyo

TEL

03-5712-5087

Homepage URL


Email

chiken@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



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 19 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2013 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study


Management information

Registered date

2013 Year 09 Month 19 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=R000013799


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name