UMIN-CTR Clinical Trial

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