Clinical trial NCT05613127: To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis A
Hep A
Keywords: Hepatitis A
Hepatitis A vaccine
Vaccine
Hep A
HAV
Lead sponsor: Boryung Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 106
Sex: ALL
Minimum age (years): 24
Maximum age (years): 15
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 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.

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

Primary outcomes:
measure: Anti-HAV seroconversion rate at 4 weeks after the second vaccination
timeFrame: At Visit 6 (7 months after Day 1: first vaccination)
Secondary outcomes:
measure: GMCs (Geometric Mean Concentrations) measured with anti-HAV antibody titers at before the first vaccination and 4 weeks after the second vaccination
timeFrame: At Visit 6 (7 months after Day 1: first vaccination)
measure: 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
timeFrame: At Visit 6 (7 months after Day 1: first vaccination)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
Study officials:
References: