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

NCT ID: NCT05613127

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-11-30

Brief Summary

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).

Detailed 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.

Conditions

Hepatitis A; Hep A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Test group

Inactivated Hepatitis A vaccine

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

Control group

Inactivated Hepatitis A vaccine

Group Type: ACTIVE_COMPARATOR

HAVRIX 720 Junior 0.5 mL

Intervention Type: BIOLOGICAL

Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

Interventions

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

Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

Intervention Type: BIOLOGICAL

HAVRIX 720 Junior 0.5 mL

Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boryung Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, , South Korea

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Countries

South Korea; Thailand

Central Contacts

Seoyeon Hong, BS

Role: CONTACT

brbio_co@boryungbio.co.kr

+82-2-740-4087

Hari Jeon, PharmD

Role: CONTACT

hrjeon@boryungbio.co.kr

+82-2-740-4228

Facility Contacts

Jong-Hyun Kim, MD

Role: primary

Tavitiya Sudjaritruk, M.D.

Role: primary

Other Identifiers

BR-HAV-CT-303

Identifier Type: -

Identifier Source: org_study_id