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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034064
Receipt No. 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

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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
Email 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
Email hiroko-kumashiro@lta-med.com

Sponsor
Institute SOUSEIKAI
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038829

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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