Clinical trial NCT03654664: To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis A Vaccine
Keywords: Hepatitis A vaccine
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 119
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion rate
timeFrame: 1 month after the second administration of the investigational product
Secondary outcomes:
measure: Antibody titer (GMT)
timeFrame: 1 month after the second vaccination
Other outcomes:
measure: 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
timeFrame: Approximately 12 months after a consent to the participation
Locations:
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St.Mary's Hospital
state: Bupyeong-gu
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vincent's Hospital.
state: Gyeonggi-do
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Changwon
country: Korea, Republic of
facility: Chanwon Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: KeiMyung University Dongsan Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Hanil General Hospital
city: Seoul
country: Korea, Republic of
facility: Korea cancer center Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical center , Eulji University
city: Wonju
country: Korea, Republic of
facility: Wonju Sevrance Christian Hospital
Study officials:
affiliation: BORYUNGPHARM. CO., LTD.
name: HJ Cho
role: STUDY_DIRECTOR
References: