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

NCT05613127 | Unknown Phase 3

• 1 other identifier: BR-HAV-CT-303
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 2

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).

Conditions

Hepatitis A; Hep A

Keywords

Hepatitis A; Hepatitis A vaccine; Vaccine; Hep A; HAV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Test group

EXPERIMENTAL

Inactivated Hepatitis A vaccine

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

Control group

ACTIVE COMPARATOR

Inactivated Hepatitis A vaccine

Biological: HAVRIX 720 Junior 0.5 mL

Interventions

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

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

Test group

HAVRIX 720 Junior 0.5 mL BIOLOGICAL

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

Control group

Eligibility Criteria

• Age: 24 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Tympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccination
• Uncontrolled epilepsy or neurological disorder
• History of thrombocytopenia or has a risk of bleeding
• History of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccine
• Severe acute or chronic infectious disease on the day of vaccination
• Congenital / acquired immunodeficiency or receiving immunosuppressive therapy
• 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)
• Administration of any other vaccine within 4 weeks prior to Screening
• Planned administration of any other vaccine within 4 weeks after the last vaccination of the investigational product
• Administration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to Screening
• Currently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to Screening
• Ineligibility for participate in the study for other reasons as determined by the investigator

Sponsors & Collaborators

• Boryung Biopharma Co., Ltd.: lead

Study Sites (2)

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

Suwon, 16247, South Korea

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Hepatitis A; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Central Study Contacts

Seoyeon Hong, BS

CONTACT

+82-2-740-4087; brbio_co@boryungbio.co.kr

Hari Jeon, PharmD

CONTACT

+82-2-740-4228; hrjeon@boryungbio.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); TH (1)