To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

Hepatitis A Vaccine Clinical Trial

— VITHA-C  

Official title:

A Randomized, Double-blind, Multi-center, Active-controlled, Parallel-designed, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Korean Healthy Children Aged 12~23 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654664
• Other study ID #: BR-HAV-CT-301
• Status: Completed
• Phase: Phase 3
• Start date: June 20, 2017
• Est. completion date: June 24, 2019

Study information

• Verified date: July 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

Description:

The objective of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose (administered twice in total at an interval of 6 months) of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months. For this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 23 Months

Eligibility

Inclusion Criteria:

• A child whose parents or representative provided written consent
• A Korean child aged 12-23 months on the day of the first vaccination
• No history of hepatitis A or a having hepatitis A vaccination
• A child who was determined by the investigator that there is no problem with the participation in the clinical study according to the medical history and physical examination results

Exclusion Criteria:

• Tympanic temperature of 38? or above within 48 hours prior to the vaccination or on the day of vaccination
• Moderate to severe acute or chronic infectious disease on the day of vaccination
• History of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines
• Disorders in the immune system, or congenital or acquired immunodeficient diseases
• Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
• A child with uncontrolled epilepsy or neurological disorders
• Planned with other vaccine within 4 weeks after the vaccination date
• Administered with other vaccine within 4 weeks prior to the vaccination date
• Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the vaccination date
• A child who has participated or is participating in another clinical trial within 12 weeks prior to the vaccination date(systemic corticosteroids administered at doses corresponding to =0.5 mg/kg/day of prednisolone for 14 consecutive days or less is exceptionally allowed)
• Other reasons not specified above that, in the opinion of the investigator, may make the subject ineligible to participate in the study

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis A Vaccine

Intervention

Biological:
• Inactivated hepatitis A vaccine
Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
• Havrix Inj
720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Chanwon Fatima Hospital	Changwon
Korea, Republic of	KeiMyung University Dongsan Medical Center	Daegu
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St.Mary's Hospital	Incheon	Bupyeong-gu
Korea, Republic of	Hanil General Hospital	Seoul
Korea, Republic of	Korea cancer center Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical center , Eulji University	Seoul
Korea, Republic of	The Catholic University of Korea, St.Vincent's Hospital.	Suwon-si	Gyeonggi-do
Korea, Republic of	Wonju Sevrance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions, physica	Adverse events observed within 30 minutes after vaccination, solicited adverse events/adverse drug reactions, and unsolicited adverse events/adverse drug reactions through a diary, serious adverse events/adverse drug reactions, physical examination	Approximately 12 months after a consent to the participation
Primary	Seroconversion rate	Seroconversion criteria: Anti-HAV 20 IU/L or above	1 month after the second administration of the investigational product
Secondary	Antibody titer (GMT)	The basic statistics of the antibody titer (GMT) at 1 month after the second vaccination	1 month after the second vaccination