UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004631 |
|---|---|
| Receipt number | R000005514 |
| Scientific Title | Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago |
| Date of disclosure of the study information | 2010/11/30 |
| Last modified on | 2014/09/04 15:51:25 |
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Basic information
Public title
Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
Acronym
Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
Scientific Title
Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
Scientific Title:Acronym
Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Immunogenicity: antibody titer on the 21st day and 6th month after vaccination
Key secondary outcomes
Immunogenicity: antibody titer on the 21st day and 6th month after vaccination
Efficacy: morbidity of influenza during influenza season in 2010-201
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Single vaccination of seasonal influenza vaccine (0.5ml) subcutaneously.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese healthy adults of 20 years old and over
2) Persons who received non-adjuvanted pandemic influenza H1N1 vaccination and persons who received AS03A-adjuvanted pandemic influenza H1N1 vaccination in 2009
3) Persons who give informed consent written voluntarily before participation in the study
4)Persons who can obey instrucions, keep diary, and tell side effects.
Key exclusion criteria
1) Persons who have ever had serious adverse reactions after vaccination of non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine.
2) Persons who were given non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine for the last 10 months
3) Persons who have had seasonal influenza vaccination (2010/2011)
4) Persons who have ever showed anaphylaxis due to food or drugs
5) Persons who had past history of cardiovascular diseases, hematological diseases, pulmonary diseases, liver diseases, renal diseases, neurological diseases, and psychiatric diseases.
6) Persons who have had Guillain-Barre syndrome or acute disseminated encephalomyelitis
7) Persons who were given new drugs by participating the other trial within four months in the past.
8) Persons who were given live vaccine within 27 days in the past or inactivate vaccine within 6 days in the past.
9) Persons who will be given the other vaccine during this study.
10) Persons who were given blood transfusion or gamma globulin within 3 months in the past or who were given a great amount of gamma globulin (over 200 mg/kg) within 6 months in the past.
11) Persons who are not appropriate to participate in this study because of some reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Nagai M.D., Ph.D. |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Diseases
Zip code
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Diseases
Zip code
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
National Hospital Organization, Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Research in National Hospital Organization Tokyo National Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2014 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005514
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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