UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long term follow-up for infants who was enrolled at 2 months of age into 'Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants'
Title of the study (Brief title)	Long term follow-up for infants who was enrolled at 2 months of age into 'Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants'
Region	Japan

Condition
Condition	NA
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider the appropriate injection needle and the insertion depth at the time of the subcutaneous and intramuscular vaccination in Japanese infants
Basic objectives2	Others
Basic objectives -Others	To consider the appropriate injection needle and the insertion depth at the time of the subcutaneous and intramuscular vaccination in Japanese infants
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	NA
Key secondary outcomes

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	Device,equipment
Interventions/Control_1	Using an ultrasonic echo, obtains the tomographic image information about the structure of skin and muscle tissue .
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	3 months-old <=
Age-upper limit	15 months-old >=
Gender	Male and Female
Key inclusion criteria	(1) Infant whose written consent form is obtained from his/her representative for participation in this study. (2) Infant obtained written consent form from his.her representative at the age of 2 months old at enrolment of main study. (3) Infant who has grown stably after birth. Even if an infant was suffering not severe transient acute disease or not severe chronic disease(common cold, upper respiratory inflammation, etc), participation in this study would be allowed when investigator medically judges the disease dose not affect the measurement items. (4) Japanese(the infant was born in Japan, and his/her all 4 grandparents are Japnese with speaking Japanease)
Key exclusion criteria	(1) infant who has an abnormality in the measurement target site. (2) infant with who investigator judges stable and circumference measurements and image inspection is difficult. (3) infant who is suffering from severe acute and chronic disease. (4) infant who has an experience of any damage in the arms or legs. (5) infant who has or experienced all of neurological or muscle disease. (6) Other, infant who investigator judges ineligible as a subject. (7) infant whose written consent form is not obtained by his/her representative's own free will.
Target sample size	30

Research contact person
Name of lead principal investigator	Tesuo Nakayama
Organization	Kitasato Univercity, Kitasato Institute for Life Science
Division name	Department of Infection Control and Immunology, Laboratory of Viral Infection I
Address	5-9-1 Shirokane, Minato-ku, Tokyo 108-8641
TEL	03-3444-6161
Email	tetsuo-n@lisci.kitasato-u.ac.jp

Public contact
Name of contact person	Keitaro Yatabe
Organization	Japan Vaccine Co.,Ltd
Division name	Clinical Development & Medical Affairs Division, Medical Affairs Group
Address	6 Yonbancho Chiyoda-ku Tokyo 102-0081 Japan
TEL	03-5213-2735
Homepage URL
Email	yatabe.keitaro.d7@japanvaccine.co.jp

Sponsor
Institute	Japan Vaccine Co.,Ltd
Institute
Department

Funding Source
Organization	Japan Vaccine Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	静岡厚生連　静岡厚生病院（静岡県） 東京都済生会中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 03 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 08 Month 26 Day
Last follow-up date	2016 Year 10 Month 17 Day
Date of closure to data entry	2016 Year 10 Month 17 Day
Date trial data considered complete	2017 Year 04 Month 21 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Long term follow-up for infants who was enrolled at 2 months of age into 'Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants(UMIN000017591)'

Management information
Registered date	2015 Year 08 Month 03 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021443