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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011799
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Clinical Research Center,
National Hospital Organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013796


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