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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018530
Receipt No. R000021443
Scientific 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'
Date of disclosure of the study information 2015/08/03
Last modified on 2018/10/11

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Basic information
Public 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'
Acronym 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'
Scientific 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'
Scientific Title:Acronym 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
1st name
Middle name
Last name Tesuo Nakayama
Organization Kitasato Univercity, Kitasato Institute for Life Science
Division name Department of Infection Control and Immunology, Laboratory of Viral Infection I
Zip code
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
1st name
Middle name
Last name Keitaro Yatabe
Organization Japan Vaccine Co.,Ltd
Division name Clinical Development & Medical Affairs Division, Medical Affairs Group
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
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

Other
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

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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