UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034064 |
|---|---|
| Receipt number | R000038829 |
| Scientific Title | Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age. |
| Date of disclosure of the study information | 2018/09/11 |
| Last modified on | 2020/09/09 19:56:48 |
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Basic information
Public title
Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.
Acronym
Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.
Scientific Title
Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.
Scientific Title:Acronym
Study on safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, in infants under one year of age.
Region
| Japan |
Condition
Condition
Prevention of infection of hepatitis B.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, after each shot, when vaccinated according to the routine vaccination schedule.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Type, severity, timing, duration, and frequency of adverse events and side effects occurred within 28 days after vaccination of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL is collected. This information is collected after every 3 doses of vaccination.
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
| 2 | months-old | <= |
Age-upper limit
| 6 | months-old | > |
Gender
Female
Key inclusion criteria
1, Infant without previous vaccination of hepatitis B vaccines, and who got 1st shot of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, according to routine vaccination schedule.
2, Infant whose legal representative gives written informed consent.
Key exclusion criteria
1, Infant who does not plan to get 3 doses of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL, according to routine vaccination schedule.
4, Infant judged not appropriate for this study by study physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinpo |
| Middle name | |
| Last name | Irie |
Organization
SOUSEIKAI
Division name
CEO
Zip code
813-0017
Address
3-5-1 Kashiiteriha, Higashi-ku, Fukuoka
TEL
0926623551
junko-manabe@lta-med.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kumashiro |
Organization
SOUSEIKAI Hakata Clinic
Division name
Planning & Coordination Dept.
Zip code
812-0025
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL
0922837701
Homepage URL
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
SOUSEIKAI
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Hakata Clinic Institutional Review Board
Address
6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Tel
0922837701
miyako-koga@lta-med.com
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
①高崎小児科医院（福岡県）
②医療法人 しんどう小児科医院（福岡県）
③医療法人 やました小児科医院（福岡県）
④医療法人 横山小児科医院（福岡県）
⑤医療法人 きよまつ小児科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 11 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Type, severity, timing, duration, and frequency of adverse events and side effects occurred within 28 days after vaccination of HEPTAVAX-II Aqueous Suspension for Injection Syringes 0.25mL is collected. This information is collected after every 3 doses of vaccination.
Management information
Registered date
| 2018 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038829
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