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
1 other identifier
interventional
119
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2017
CompletedFirst Submitted
Initial submission to the registry
August 29, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2019
CompletedJuly 7, 2023
July 1, 2023
2 years
August 29, 2018
July 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate
Seroconversion criteria: Anti-HAV 20 IU/L or above
1 month after the second administration of the investigational product
Secondary Outcomes (1)
Antibody titer (GMT)
1 month after the second vaccination
Other Outcomes (1)
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
Approximately 12 months after a consent to the participation
Study Arms (2)
inactivated hepatitis A vaccine
EXPERIMENTALA 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
Havrix Inj
ACTIVE COMPARATORA 0.5ml dose is administered twice in total at an interval of 6 months to healthy children aged 12-23 months.
Interventions
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Bupyeong-gu, 403-720, South Korea
The Catholic University of Korea, St.Vincent's Hospital.
Suwon, Gyeonggi-do, 442-723, South Korea
Korea University Ansan Hospital
Ansan, 15355, South Korea
Chanwon Fatima Hospital
Changwon, 51394, South Korea
KeiMyung University Dongsan Medical Center
Daegu, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Hanil General Hospital
Seoul, 01450, South Korea
Korea cancer center Hospital
Seoul, 01812, South Korea
Nowon Eulji Medical center , Eulji University
Seoul, 01830, South Korea
Wonju Sevrance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
HJ Cho
BORYUNGPHARM. CO., LTD.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2018
First Posted
August 31, 2018
Study Start
June 20, 2017
Primary Completion
June 24, 2019
Study Completion
June 24, 2019
Last Updated
July 7, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share