UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017591 |
|---|---|
| Receipt number | R000020379 |
| Scientific Title | Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants |
| Date of disclosure of the study information | 2015/05/16 |
| Last modified on | 2018/10/11 15:18:58 |
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Basic information
Public title
Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants
Acronym
Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants
Scientific Title
Evaluation of depth and thickness in skin, subcutaneous and muscle tissue at vaccination sites in Japanese infants
Scientific Title:Acronym
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
| 2 | 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, 3, 4, 5, 6, or 12-15 months old.
(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
180
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
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
yatabe.keitaro.d7@japanvaccine.co.jp
Sponsor or person
Institute
Japan Vaccine Co.,Ltd
Institute
Department
Personal name
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
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
社会医療法人 真美会 中野こども病院（大阪府）
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 | 05 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.scirp.org/Journal/PaperDownload.aspx?paperID=67124
Publication of results
Published
Result
URL related to results and publications
http://www.scirp.org/Journal/PaperDownload.aspx?paperID=67124
Number of participants that the trial has enrolled
Results
The thickness of the epidermis was 1.44 - 1.54 mm (95% CI), and the lengths from the skin surface to the muscle fascia and bone were 11.52 - 12.28 mm (95% CI), and 25.66 - 26.93 mm (95% CI), respectively, at the anterolateral thigh. At the center of the deltoid muscle, skin thickness was similar to that at the thigh, furthermore the lengths from the skin surface to the muscle fascia and bone were 8.49 - 9.10 mm (95% CI), and 17.38 - 18.31 mm (95% CI), respectively. The lengths from the skin surface to the muscle fascia and bone were 1 - 2 mm shorter in 2-month-old infants than those in older generations. Therefore, the appropriate needle length for intramuscular injections in Japanese infants was 16 mm (5/8 inch) at any age and sites, and with 25 mm (1 inch) needles at a 90-degree angle being associated with the risk of over-penetration.
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
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 15 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020379
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