Immunologic response to hepatitis B immunization in children post liver transplantatio
Phase 4
Recruiting
- Conditions
- Safety and efficacy of hepatitis B vaccine, standard compare to double dose in short and long term follow-up.infection, bleeding, pain
- Registration Number
- TCTR20180723002
- Lead Sponsor
- Chulalonkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Participants age less than 18 years old, post liver transplantation, do not on steroid as immunosuppressants, antiHBs antibody less than 100 mIU/m
Exclusion Criteria
Participant who has serious illness such as fever, loss follow up, on steroid as immunosuppressant therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AntiHBs antibody level after full immunization in short term follow-up 12 months after the first dose of hepatitis B vaccine and then every 3-6 months follow-up until anti-HBs less than 100 mIU/mL blood sampling,Humoral and cellular response in long term follow-up 12 months after complete 3-dose regimen and then every 3-6 months at clinic visits until anti-HBs less than 100 mIU/mL anti-HBs and specific T cells
- Secondary Outcome Measures
Name Time Method Safety of hepatitis B vaccine 1 month after vaccination Adverse effect of vaccine