To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

Boryung

Status and phase: Not yet enrolling; Phase 3

Conditions: Hepatitis A; Hep A

Treatments: Biological: HAVRIX 720 Junior 0.5 mL; Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05613127

BR-HAV-CT-303

Details and patient eligibility

About

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

Full description

The purpose of this study is to evaluate immunogenicity and safety of inactivated hepatitis A vaccine in healthy children aged from 24 months to 15 years when administered an initial dose followed by a booster dose (a total of 2 doses administered with 6 months interval).

This study is a two-group comparative study using a marketed inactivated hepatitis A vaccine (HAVRIX®, manufactured by GSK) as a control. The study will demonstrate non-inferiority of the test vaccine compared to the control vaccine.

Enrollment: 106 estimated patients

Sex: All

Ages: 24 months to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccination
2. Subjects with no history of hepatitis A and no previous vaccination against hepatitis A
3. Written informed consent obtained from the subject's legal representative (parents or representative)
4. Children who no health issues based on medical history and physical examination as judged by the investigator

Exclusion Criteria

1. Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
2. Uncontrolled epilepsy or neurological disorder
3. History of thrombocytopenia or has a risk of bleeding
4. History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
5. Severe acute or chronic infectious disease on the day of vaccination
6. Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
7. Received immunosuppressive dose of systemic corticosteroids within 12 weeks prior to the first vaccination with the IP (Investigational Product) (equivalent potency of ≥ prednisolone 20 mg/day or equivalent potency of ≥ prednisolone 2.0 mg/kg/day in < 10kg of body weight for ≥ 14 consecutive days)
8. Administration of any other vaccine within 4 weeks prior to Screening
9. Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
10. Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
11. Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
12. Ineligibility for participate in the study for other reasons as determined by the investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups

Test group

Experimental group

Description:

Inactivated Hepatitis A vaccine

Treatment:

Biological: Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL

Control group

Active Comparator group

Description:

Inactivated Hepatitis A vaccine

Treatment:

Biological: HAVRIX 720 Junior 0.5 mL