- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654664
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-C)
A Randomized, Double-blind, Multi-center, Active-controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Korean Healthy Children Aged 12~23 Months
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Ansan, Korea, Republic of, 15355
- Korea University Ansan Hospital
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Changwon, Korea, Republic of, 51394
- Chanwon Fatima Hospital
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Incheon, Korea, Republic of
- Gachon University Gil Hospital
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Seoul, Korea, Republic of, 01450
- Hanil General Hospital
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Seoul, Korea, Republic of, 01812
- Korea Cancer Center Hospital
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Seoul, Korea, Republic of, 01830
- Nowon Eulji Medical center , Eulji University
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Wonju, Korea, Republic of
- Wonju Sevrance Christian Hospital
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Bupyeong-gu
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Incheon, Bupyeong-gu, Korea, Republic of, 403-720
- The Catholic University of Korea, Incheon St.Mary's Hospital
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Gyeonggi-do
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Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
- The Catholic University of Korea, St.Vincent's Hospital.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
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Active Comparator: Havrix Inj
A 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
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720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion rate
Time Frame: 1 month after the second administration of the investigational product
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Seroconversion criteria: Anti-HAV 20 IU/L or above
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1 month after the second administration of the investigational product
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibody titer (GMT)
Time Frame: 1 month after the second vaccination
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The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination
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1 month after the second vaccination
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety endpoints Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions, physica
Time Frame: Approximately 12 months after a consent to the participation
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Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions, physical examination
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Approximately 12 months after a consent to the participation
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: HJ Cho, BORYUNGPHARM. CO., LTD.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BR-HAV-CT-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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