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

BR-HAV-CT-301

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.

2017-06-20

2019-06-24

2019-06-24

Completed

Early phase I

119

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 119, 'type': 'ACTUAL'}}

2023-07-07