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To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

NCT03654664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-07-07

No results posted yet for this study

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.

Conditions

  • Hepatitis A Vaccine

Interventions

BIOLOGICAL

Inactivated hepatitis A vaccine

Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)

BIOLOGICAL

Havrix Inj

720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • HJ Cho · BORYUNGPHARM. CO., LTD.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2019-06-24
Completion
2019-06-24

Countries

  • South Korea

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 NCT03654664 on ClinicalTrials.gov