UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032930 |
|---|---|
| Receipt number | R000037538 |
| Scientific Title | 13-valent pneumococcal conjugate vaccine (PCV13) administered concurrently with inactivated influenza vaccine for persons over 65 years |
| Date of disclosure of the study information | 2018/06/08 |
| Last modified on | 2018/06/08 16:50:11 |
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Basic information
Public title
13-valent pneumococcal conjugate vaccine (PCV13) administered concurrently with inactivated influenza vaccine for persons over 65 years
Acronym
Adverse reaction of PCV13 with IIV in elderly
Scientific Title
13-valent pneumococcal conjugate vaccine (PCV13) administered concurrently with inactivated influenza vaccine for persons over 65 years
Scientific Title:Acronym
Adverse reaction of PCV13 with IIV in elderly
Region
| Japan |
Condition
Condition
Pneumococcal Vaccine
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adverse reaction of PCV13
Basic objectives2
Others
Basic objectives -Others
Adverse reaction of PCV13
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reaction in 14 days
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
13-valent pneumococcal conjugate vaccine
Key exclusion criteria
N/A
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Kawai |
Organization
Kawai Clinic
Division name
Medicine in general
Zip code
Address
4-32 Kanazono-cho Gifu-shi, Gifu, 500- 8113
TEL
058-245-0564
nkawai@city.gifu.med.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chigusa Iwasaki |
Organization
RICERCA CLINICA Co.,Ltd
Division name
Clinical support center
Zip code
Address
2-18-30 Yaesuhakata Bld.6F, Hakataeki Higashi, Hakata-ku, Fukuoka-shi, Fukuo ka 812-0013
TEL
092-435-1150
Homepage URL
secretary@ricercaclinica.jp
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 06 | Month | 08 | 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
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 01 | Day |
Other
Other related information
Pneumococcal Vaccine
Management information
Registered date
| 2018 | Year | 06 | Month | 08 | Day |
Last modified on
| 2018 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037538
