UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002439 |
|---|---|
| Receipt number | R000002984 |
| Scientific Title | Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination - |
| Date of disclosure of the study information | 2009/09/03 |
| Last modified on | 2014/09/04 15:49:38 |
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Basic information
Public title
Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination -
Acronym
Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination -
Scientific Title
Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination -
Scientific Title:Acronym
Clinical study on revaccination with pneumococcal polysaccharide vaccine. -Safety and immunogenicity of revaccination -
Region
| Japan |
Condition
Condition
Chronic lung disease
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and immunogenicity of revaccination with pneumococcal polysaccharide vaccine in patients with chronic lung disease who received the first vaccination at least 5 years ago.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety: body temperature, local adverse reaction and systemic symptoms for 6 days after revaccination. Clinical symptom for 14 days after revaccination. Blood tests (both general and biochemical items) for pre- and the 14th day after revaccination. Any other adverse reactions observed for 28 days after revaccination.
Key secondary outcomes
Immunogenicity: antibody titer on the 28th day after revaccination.
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
Single vaccination of pneumococcal polysaccharide vaccine (0.5 ml) intramuscularly or 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic lung disease of 65 years old and over.
2) Patients who received any multi-valent pneumococcal polysaccharide vaccine more than 5 years prior to the study enrollment.
3) Patients whose blood specimen was collected for antibody titration upon the first vaccination, and has been kept in the clinical study organization.
4) Patients who understand the procedure of this study and give informed consent in written voluntarily before participation in the study.
Key exclusion criteria
1) Patients under treatment of radiotherapy and immunosuppressant at present and/or soon after revaccination.
2) Patients who have fever obviously.
3) Patients who have serious acute diseases obviously.
4) Patients who have ever showed anaphylaxis due to ingredient(s) of this vaccine.
5) Patients who are not appropriate to be vaccinated for other reasons.
Target sample size
80
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
042-491-2111
Public contact
Name of contact person
| 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
042-491-2111
Homepage URL
hnagai-in@tokyo-hosp.jp
Sponsor or person
Institute
National Hospital Organization, Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Laboratory of Clinical Research in Infectious Diseases, International Research Center for Infectious Diseases, Research Institute for Microbial Diseases, Osaka University
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
独立行政法人国立病院機構東京病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 03 | 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
| 2009 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 03 | 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=R000002984
