UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007027 |
|---|---|
| Receipt number | R000008294 |
| Scientific Title | Efficacy and safety of the pandemic influenza A(H5N1) vaccination on whether the sequential hetero-strains vaccination would provide wide range of immunogenicity, and whether single-shot vaccination would develop effective priming. |
| Date of disclosure of the study information | 2012/01/10 |
| Last modified on | 2016/02/24 11:00:07 |
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Basic information
Public title
Efficacy and safety of the pandemic influenza A(H5N1) vaccination on whether the sequential hetero-strains vaccination would provide wide range of immunogenicity, and whether single-shot vaccination would develop effective priming.
Acronym
Efficacy and safety of the pandemic influenza A(H5N1) vaccination on sequential heterologous strains administration and single administration for priming (H5N1_VI hetero-sequence and single priming)
Scientific Title
Efficacy and safety of the pandemic influenza A(H5N1) vaccination on whether the sequential hetero-strains vaccination would provide wide range of immunogenicity, and whether single-shot vaccination would develop effective priming.
Scientific Title:Acronym
Efficacy and safety of the pandemic influenza A(H5N1) vaccination on sequential heterologous strains administration and single administration for priming (H5N1_VI hetero-sequence and single priming)
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 and cross-immunity after immunization with the heterologous strain to the healthy adult volunteers, who could be vaccinated with the different strain 3 weeks before. It evaluate an immunogenicity of the pandemic strain with other strains before the pandemic strain is manufactured
2) Evaluation of cross-immunity 3weeks after additional single dose of adjuvanted influenza A (H5N1) vaccine of Vietnam strain or Indonesia strain on the healty adult volunteers, who are vaccinated with with the homorologous strain or the hetero strain 6 months before., The immunogenicity with single priming is evaluated.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of neutralizing antibody to Qinghai, Vietnam, Indonesia and Anhui strain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
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 Vietnam strain, 3weeks later, second dose of that of Indonesia strain.
Interventions/Control_2
Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after single-dose of adjuvanted influenza A (H5N1) vaccine of Vietnam strain or Indonesia strain, 6months later, second dose of the homorologous or heterogenous strain.
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
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 fromsubjects)
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
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
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
2-5-23,Higasigaoka,Meguro-ku,Tokyo
TEL
Homepage URL
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
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
| 2012 | Year | 01 | Month | 10 | 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
| 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
Other related information
Management information
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=R000008294
| Research Plan | |
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