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NCT05613127
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs
Conditions: Hepatitis A, Hep A
Sex: All
Ages: 24 Months – 15 Years
Healthy volunteers: 1
Phase: PHASE3
Enrollment: 106
Sponsor: Boryung Biopharma Co., Ltd.
Location: Korea, Republic of
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).
Eligibility Criteria
Inclusion Criteria:Healthy male or female children ≥ 24 months and ≤ 15 years old on the day of first vaccinationSubjects with no history of hepatitis A and no previous vaccination against hepatitis AWritten 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 investigatorExclusion CriteriaTympanic temperature of 38.0℃ or above within 48 hours prior to vaccination or on the day of vaccinationUncontrolled epilepsy or neurological disorderHistory of thrombocytopenia or has a risk of bleedingHistory of hypersensitivity to the following: neomycin, formaldehyde, gentamicin sulfate, any vaccineSevere acute or chronic infectious disease on the day of vaccinationCongenital / acquired immunodeficiency or receiving immunosuppressive therapyReceived 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 ScreeningPlanned administration of any other vaccine within 4 weeks after the last vaccination of the investigational productAdministration of immunoglobulins or blood products or received blood transfusion within 12 weeks prior to ScreeningCurrently participating in another clinical trial or administered / applied other investigational product / medical device within 6 months prior to ScreeningIneligibility for participate in the study for other reasons as determined by the investigator
Source: ClinicalTrials.gov (NCT05613127). StuddyBuddy aggregates publicly available trial information.