UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004392 |
|---|---|
| Receipt number | R000005239 |
| Scientific Title | Immunogenicity of Pandemic Influenza A 2009 (H1N1) vaccination in health care workers |
| Date of disclosure of the study information | 2010/10/15 |
| Last modified on | 2010/10/15 17:38:23 |
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Basic information
Public title
Immunogenicity of Pandemic Influenza A 2009 (H1N1) vaccination in health care workers
Acronym
2009 influenza A(H1N1) vaccination in health care workers
Scientific Title
Immunogenicity of Pandemic Influenza A 2009 (H1N1) vaccination in health care workers
Scientific Title:Acronym
2009 influenza A(H1N1) vaccination in health care workers
Region
| Japan |
Condition
Condition
Pandemic influenza A 2009 (H1N1)
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in health care workers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the immunogenicity of a 2009 influenza A(H1N1) vaccine in health care workers.
Key secondary outcomes
To assess the safety of a 2009 influenza A(H1N1) vaccine in health care workers.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-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
Subcutaneus injection of 15 µg of hemagglutinin antigen dose of monovalent, unadjuvanted 2009 influenza A(H1N1) vaccine in a 1-dose regimen.
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatrician working in Kitano Hospital
Key exclusion criteria
excluding the above-mentioned
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuko Hata |
Organization
The Tazuke Kofukai Medical Research Institute
Division name
Department of Infectious Diseases
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka Japan
TEL
06-6312-8824
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Tazuke Kofukai Medical Research Institute
Division name
Clinical research section
Zip code
Address
2-4-20 Ohgimachi Kitaku Osaka Japan
TEL
06-6312-1221
Homepage URL
rinshou@kitano-hp.or.jp
Sponsor or person
Institute
The Tazuke Kofukai Medical Research Institute
Institute
Department
Personal name
Funding Source
Organization
The Tazuke Kofukai Medical Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Prefectural Institute of Health
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
財団法人 田附興風会医学研究所 北野病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 15 | 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
Overall, 7 of 15 participants had neutralizing antibody titers of 1:40 or greater after a single H1N1 vaccination were and 46.7%(7/15).
The seroconversion rates of neutralizing antibody titers of 1:40 or greater before and after vaccination were 6.3% (1/16) and 50% (8/16), respectively.
Only at the age of 34 achieved titers of 1:40 or greater. The age of 35 or more did achieve titers of 1:40 or greater(0/6). The seroconversion rates of the younger group was 77.8%(7/9).
Systemic adverse events following vaccination has not seen in all HCWs.
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
| 2009 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 15 | Day |
Last modified on
| 2010 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005239
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
