UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017959 |
|---|---|
| Receipt number | 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 16:13:19 |
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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
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
hiroko-kumashiro@lta-med.com
Sponsor or person
Institute
Kaketsuken (The Chemo-Sero-Therapeutic Research Institute)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020783
