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To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in Healthy Children Aged From 24mons-15yrs

NCT05613127 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2022-11-14

No results posted yet for this study

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).

Conditions

  • Hepatitis A
  • Hep A

Interventions

BIOLOGICAL

Boryung Hepatitis A Vaccine Pre-Filled Syringe Inj. 0.5 mL

Dosage and administration: pre-iflled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

BIOLOGICAL

HAVRIX 720 Junior 0.5 mL

Dosage and administration: pre-filled syringe, IM injection of 0.5mL will be given for 2 times with 6-months interval.

Sponsors & Collaborators

  • Boryung Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-07-31
Completion
2024-11-30

Countries

  • South Korea
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613127 on ClinicalTrials.gov