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

Hepatitis A Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter, Multinational, Active-controlled, Parallel-designed Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24months to 15yrs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05613127
• Other study ID #: BR-HAV-CT-303
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2022
• Est. completion date: November 2024

Study information

• Verified date: November 2022
• Source: Boryung Biopharma Co., Ltd.
• Contact: Seoyeon Hong, BS
• Phone: +82-2-740-4087
• Email: brbio_co[@]boryungbio.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, ST. Vincent's Hospital	Suwon
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Biopharma Co., Ltd.

Countries where clinical trial is conducted

Korea, Republic of,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HAV seroconversion rate at 4 weeks after the second vaccination	Seroconversion: anti-HAV = 20 mIU/mL after the second vaccination in subjects with anti-HAV < 20 mIU/mL at baseline	At Visit 6 (7 months after Day 1: first vaccination)
Secondary	GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination	GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination	At Visit 6 (7 months after Day 1: first vaccination)
Secondary	GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination	GMR (Geometric Mean Ratio, GMC Visit 6/GMC Visit 1) measured with anti-HAV antibody titers at 4 weeks after the second vaccination compared to those before the first vaccination	At Visit 6 (7 months after Day 1: first vaccination)