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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017959
Receipt No. R000020783
Scientific Title Study on interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) in infants under one year old.
Date of disclosure of the study information 2015/06/20
Last modified on 2016/07/07

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Basic information
Public title Study on interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) in infants under one year old.
Acronym Interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast)
Scientific Title Study on interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) in infants under one year old.
Scientific Title:Acronym Interchangeability of Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast)
Region
Japan

Condition
Condition -Prevention of infection of hepatitis B.
-Prevention of mother-to-child transmission of hepatitis B virus (used with Anti-HBs Human Immune Globulin)
-Prevention of onset of hepatitis B after accidental contamination of HBsAg positive and HBeAg positive blood (used with Anti-HBs Human Immune Globulin).
Classification by specialty
Gastroenterology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safety and immunogenicity of two different marketed Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast), when vaccinated three times in different sequences in infants (<=2 months and >6 months)
Basic objectives2 Others
Basic objectives -Others Safety and immunogenicity.
Immunogenicity such as seroconversion rate by measuring antibody titer of HBsAg
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety.
Types, severity, the number of days after vaccination, duration, and frequency of adverse events and side effects.
Key secondary outcomes Immunogenicity.
Change of HBs antibody (seroconversion rate)

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Bim-Hep-Bim.
Interventions/Control_2 0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Hep-Bim-Bim.
Interventions/Control_3 0.25mL of Bimmugen(r) 0.25mL (Bim) and 0.25mL of Heptavax (r) -II 0.5mL (Hep) are vaccinated in the sequence of Hep-Hep-Bim.
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 Male and Female
Key inclusion criteria 1, Infant whose age at the time of first vaccination is <= 2 months and > 6 months.
2, Infant without previous vaccination of recombinant adsorbed hepatitis B vaccines (prepared from yeast), and whose vaccination history is confirmed with a maternal handbook etc.
3, Infant whose legal representative gives written informed consent.
Key exclusion criteria 1, Infant with fever.
2, Infant with sever acute disease.
3, Infant allergic to substance of study vaccines.
4, Infant judged not appropriate for this study by study physician.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Irie
Organization SOUSEIKAI
Division name CEO
Zip code
Address 6-18 Tenyamachi, Hakata-ku, Fukuoka,812-0025
TEL 0922837701
Email junklo-manabe@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Kumashiro
Organization SOUSEIKAI Hakata Clinic
Division name Planning & Coordination Dept.
Zip code
Address Random Square (5th-7th floors) 6-18
TEL 0922837701
Homepage URL
Email hiroko-kumashiro@lta-med.com

Sponsor
Institute Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)
Institute
Department

Funding Source
Organization Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 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
2015 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
All subjects acquired the antibody titer 10mIU/mL and over, which is necessary for infection prevention, after all triplet vaccination sequences of Bimmugen and  Heptavax -II adopted in this study. 
Serious adverse reaction was not observed.
Considering the above, usability / interchangeability of two different Recombinant Adsorbed Hepatitis B Vaccines (prepared from yeast) was confirmed.
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 10 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 20 Day
Last follow-up date
2016 Year 02 Month 09 Day
Date of closure to data entry
2016 Year 04 Month 12 Day
Date trial data considered complete
2016 Year 04 Month 12 Day
Date analysis concluded
2016 Year 04 Month 12 Day

Other
Other related information

Management information
Registered date
2015 Year 06 Month 18 Day
Last modified on
2016 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020783

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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