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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032930
Receipt No. R000037538
Official scientific title of the study 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

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Basic information
Official scientific title of the study 13-valent pneumococcal conjugate vaccine (PCV13) administered concurrently with inactivated influenza vaccine for persons over 65 years
Title of the study (Brief title) 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 Naoki Kawai
Organization Kawai Clinic
Division name Medicine in general
Address 4-32 Kanazono-cho Gifu-shi, Gifu, 500- 8113
TEL 058-245-0564
Email nkawai@city.gifu.med.or.jp

Public contact
Name of contact person Chigusa Iwasaki
Organization RICERCA CLINICA Co.,Ltd
Division name Clinical support center
Address 2-18-30 Yaesuhakata Bld.6F, Hakataeki Higashi, Hakata-ku, Fukuoka-shi, Fukuo ka 812-0013
TEL 092-435-1150
Homepage URL
Email secretary@ricercaclinica.jp

Sponsor
Institute Japan Physicians Association
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 12 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037538

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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