Evaluation of Immunogenicity and Safety of Hepatitis A Vaccine in Adolescents

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000407

Enrollment

300

Registered

2012-04-19

Start date

2012-05-09

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine : 1.Evaluation of immunity of hepatitis A in adoescents Subjects: 150 adolescents(ages 13-18 years)who received hepatitis A vaccination in the past and who agree to this study Meth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Seroconversion Rate;anti-HAV IgG levels;antibody fold increase	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSeo Hee Yoon

Ewha Womans University Medical Center

Outcome results