UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003720 |
|---|---|
| Receipt number | R000004500 |
| Scientific Title | Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine. |
| Date of disclosure of the study information | 2010/06/07 |
| Last modified on | 2011/01/19 13:57:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.
Acronym
Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.
Scientific Title
Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.
Scientific Title:Acronym
Trial in adults aged 65 years or older to evaluate the immunogenicity of influenza vaccine.
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the immunogenicity of influenza vaccine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seroconversion rate
Seroprotection rate
Geometric mean fold rise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
vaccinate
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)written informed consent obtained from the subject.
2)healthy adults aged 65 years or older at time of the first vaccination.
Key exclusion criteria
1)history of previous administration of novel [H1N1]v vaccine.
2)clinically or virologically confirmed influenza infection within 12 months preceding the study start.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Ikematsu |
Organization
influenza vaccine Research Group
Division name
office of clinical research
Zip code
Address
6-40-8, aoba, higashi-ku, fukuoka-shi, Fukuoka Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeda |
Organization
Clinical support
Division name
Quality Management division
Zip code
Address
1-9-17-7F, tenjin, chuo-ku, fukuoka-shi, Fukuoka Japan
TEL
092-738-0500
Homepage URL
tsutomu.takeda@clinicalsupport.co.jp
Sponsor or person
Institute
influenza vaccine Research Group
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 06 | Month | 07 | 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 | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 07 | Day |
Last modified on
| 2011 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004500
