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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002439
Receipt No. 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

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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
Email

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
Email hnagai-in@tokyo-hosp.jp

Sponsor
Institute National Hospital Organization, Tokyo National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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