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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004788
Receipt No. R000005663
Scientific Title Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
Date of disclosure of the study information 2010/12/24
Last modified on 2013/11/22

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Basic information
Public title Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
Acronym A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
(H5N1_QB2)
Scientific Title Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
Scientific Title:Acronym A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components
(H5N1_QB2)
Region
Japan

Condition
Condition Prevention of influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of immunogenicity and safety of immunization to the individuals who have participated in manufacturing vaccine and potentially exposed to virus components
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of neutralizing antibody to Qinghai strain, if possible Vietnam, Indonesia and Anhui strain
Key secondary outcomes

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 participated in manufacturing influenza A (H5N1) vaccine in the institutes according to the 2010 MHLW contract

2)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 by 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 with influenza vaccine 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 (counting from the date 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 (counting from the date of vaccination).

8)Individuals who are deemed to be inappropriate by the investigator
Target sample size 300

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
Email

Public contact
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

Sponsor
Institute Clinical Research Center,
National Hospital Organization
Institute
Department

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
2010 Year 12 Month 24 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
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information prospective observational study

Management information
Registered date
2010 Year 12 Month 24 Day
Last modified on
2013 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005663

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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