UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011799
Receipt number R000013796
Scientific Title Efficacy and safety of vaccination of the influenza A (H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.
Date of disclosure of the study information 2013/09/18
Last modified on 2016/02/24 11:03:37

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Basic information

Public title

Efficacy and safety of vaccination of the influenza A (H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.

Acronym

Efficacy and safety of vaccination of the influenza A(H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.
(H5N1_Egypt interval)

Scientific Title

Efficacy and safety of vaccination of the influenza A (H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.

Scientific Title:Acronym

Efficacy and safety of vaccination of the influenza A(H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.
(H5N1_Egypt interval)

Region

Japan


Condition

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)Evaluation of immunogenicity with Egyptian strain to the healthy adult volunteers, who could be vaccinated at 3 weeks intervals. It evaluate an immunogenicity of Egyptian strain.

2)Evaluation of immunogenicity and cross-immunity after immunization with the Egyptian strain to the healthy adult volunteers, who could be vaccinated at 60days, 90days and 180days intervals. It evaluate an immunogenicity of Egyptian strain and the other strains

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of neutralizing antibody to influenza A (H5N1)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the single-dose of adjuvanted influenza A (H5N1) vaccine of Egyptian strain, 3weeks later, second dose of that of the same strain.

Interventions/Control_2

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the single-dose of adjuvanted influenza A (H5N1) vaccine of Egyptian strain, 60days later, second dose of that of the same strain.

Interventions/Control_3

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the single-dose of adjuvanted influenza A (H5N1) vaccine of Egyptian strain, 90days later, second dose of that of the same strain.

Interventions/Control_4

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the single-dose of adjuvanted influenza A (H5N1) vaccine of Egyptian strain, 180days later, second dose of that of the same strain.

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

140


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 18 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



Management information

Registered date

2013 Year 09 Month 18 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=R000013796