Evaluation of Immunogenicity and Safety of Hepatitis A Vaccine in Adolescents
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0000407
- Lead Sponsor
- Ewha Womans University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
1. Assessment of hepatitis A immunity
? adolescents(ages 13 to 18 years) who received Hepatitis A vaccine
in the past
2. Evaluation of the immunogenicity and safety after the hepatitis A vaccination and the receptivity to hepatitis A vaccination
? Adolescent who agree to this study and has no serum anti-HAV
IgG
? By the tester's judgement, Subject and/or subject's parent/legal
guardian of the subject are willing and able to follow instructions
? Before participating in this study, confirmed by medical history and
physical examination, subject should have no apparent health
problems
? subject/subject's parent or legal guardian are willing and able to
provide written informed consent
? If the subject is a woman, she should have no childbearing potential
3. A Nationwide Survey on Acceptance of Hepatitis A Vaccination among Mothers of Children aged 7-18 Years in Korea.
? mothers of children and adolescents aged 7-18 years in 2013, who agreed ths telephone- based survey.
? mothers who did not vaccinate their child with hepatitis A vaccine
1. Subject who have a history of allergic disease, or allergic reaction that can be exacerbated by the vaccine composition
2. Subject who have an acute illness(a moderate or severe disease
status with or without fever) at the time of registration
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroconversion Rate;anti-HAV IgG levels;antibody fold increase
- Secondary Outcome Measures
Name Time Method The incidence of the specified local and systemic adverse events during the 4-day follow-up period after vaccination (0-3 days) ;The incidence of the unspecified adverse events during the 31- day follow-up period after vaccination (0-30 days);The incidence of Serious Adverse Events(SAEs) during the entire study period