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Completed

NCT Number: NCT03654677

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.

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Key information

Conditions

Hepatitis A Vaccine Digestive System Diseases Hepatitis Liver Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul, Banpo-dong, Seocho-gu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 16 years or older on the day of the first vaccination
  • No history of hepatitis A or having hepatitis A vaccination
  • Provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study
  • Determined by the investigator to be able to be followed up during the study period

Exclusion criteria

  • A positive result (Anti-HAV 20 IU/L or above) in an hepatitis A antibody test at the time of screening
  • Positive hepatitis type B antigen at the time of screening
  • The following blood test results at the time of screening
  • ALT: More than 1.5 times the upper limit of normal
  • AST: More than 1.5 times the upper limit of normal
  • Total bilirubin: More than 1.5 times the upper limit of normal
  • Tympanic temperature of 38°C 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
  • Congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy
  • Received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination
  • uncontrolled epilepsy or neurological disorders
  • Administered with other vaccine within 4 weeks prior to the screening
  • Planned with other vaccine within 4 weeks after the vaccination date
  • Used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening
  • Participated in another clinical study within 12 weeks prior to the screening, or currently participating
  • Pregnant women or breast-feeding women
  • Other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study

Treatment and study plan

Inactivated hepatitis A vaccine

Biological

A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.

Havrix Inj

Biological

A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.

Primary outcomes

  1. Seroconversion rate

    Time frame: 1 month after the second vaccination

    Seroconversion criteria: Anti-HAV 20 IU/L or above

Secondary outcomes

  1. Seroconversion rate

    Time frame: 1 month after the first vaccination

    Seroconversion rate at 1 month after the first vaccination

Other outcomes

  1. Safety endpoint (Adverse events)

    Time frame: Approximately 12 months after a consent to the participation

    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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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 Healthy Youths Above 16 Years or Adults

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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