To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
- Conditions
- Hepatitis A Vaccine
- Interventions
- Biological: Inactivated hepatitis A vaccineBiological: Havrix Inj
- Registration Number
- NCT03654664
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
- Detailed Description
The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.
For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- A child whose parents or representative provided written consent
- A Korean child aged 12-23 months on the day of the first vaccination
- No history of hepatitis A or a having hepatitis A vaccination
- A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results
- Tympanic temperature of 38℃ or above within 48 hours prior to the vaccination or on the day of vaccination
- Moderate to severe acute or chronic infectious disease on the day of vaccination
- History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
- Disorders in the immune system, or congenital or acquired immunodeficient diseases
- Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
- A child with uncontrolled epilepsy or neurological disorders
- Planned with other vaccine within 4 weeks after the vaccination date
- Administered with other vaccine within 4 weeks prior to the vaccination date
- Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date
- A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to ≤0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed)
- Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description inactivated hepatitis A vaccine Inactivated hepatitis A vaccine A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months. Havrix Inj Havrix Inj A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
- Primary Outcome Measures
Name Time Method Seroconversion rate 1 month after the second administration of the investigational product Seroconversion criteria: Anti-HAV 20 IU/L or above
- Secondary Outcome Measures
Name Time Method Antibody titer (GMT) 1 month after the second vaccination The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination
Trial Locations
- Locations (10)
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
The Catholic University of Korea, St.Vincent's Hospital.
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, Incheon St.Mary's Hospital
🇰🇷Incheon, Bupyeong-gu, Korea, Republic of
KeiMyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Hanil General Hospital
🇰🇷Seoul, Korea, Republic of
Chanwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Wonju Sevrance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Korea cancer center Hospital
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical center , Eulji University
🇰🇷Seoul, Korea, Republic of