UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022806 |
|---|---|
| Receipt number | R000026217 |
| Scientific Title | Japan Pneumococcal Vaccine Effectiveness study |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2018/01/04 20:30:01 |
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Basic information
Public title
Japan Pneumococcal Vaccine Effectiveness study
Acronym
J-PAVE study
Scientific Title
Japan Pneumococcal Vaccine Effectiveness study
Scientific Title:Acronym
J-PAVE study
Region
| Japan |
Condition
Condition
Community Onset pneumonia; Community acquired and Healthcare associated pneumonia
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Infectious disease | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study
To evaluate the impact of pediatric PCV7/13 on adult pneumococcal pneumonia
Objectives
1. To determine the serotype distribution of adult pneumococcal pneumonia in Japan.
2. To monitor the PPV23 and PCV13 effectiveness on adult pneumococcal pneumonia after PCV7/13 introduction for children.
Basic objectives2
Others
Basic objectives -Others
Vaccine effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the impact of pneumococcal vaccine on adult pneumococcal pneumonia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.with compatible symptoms or physical examination with pneumonia (i.e. fever, chills or rigors, cough, sputum, pleuritic chest pain, dyspnea, dyspnea and/or tachypnea,)
2.with new pulmonary infiltrates on chest X-ray or computed tomography (CT) scan (consistent with pneumonia, improvement after treatment).
3.developed pneumonia in the first 48 hours after admission
Key exclusion criteria
A case as appeared the disease 48 hours after admission, which is regarded as Hospital Acquired Pneumonia (HAP)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Konosuke Morimoto |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of clinical medicine
Zip code
Address
1-12-4,Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL
095-819-7800
komorimo@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichiro Sando |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of clinical medicine
Zip code
Address
1-12-4,Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL
095-819-7800
Homepage URL
http://www.tm.nagasaki-u.ac.jp/internal/nekkennaika.htm
eiichiro-ymn@umin.ac.jp
Sponsor or person
Institute
Department of clinical medicine, Institute of Tropical Medicine,Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency of Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2016 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
http://www.tm.nagasaki-u.ac.jp/internal/nekkennaika.htm
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
1.The anonymized data of pneumococcal strain and patient's information including age, sex, underlying illness, vaccination history, severity of pneumonia, and hospital death or not, are used without aggressive rejection.
2.The anonymized data of sputum (including pneumococcal strain) and patient's information are used in case oral or written consent has been obtained.
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026217
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
