NCT00237991

Brief Summary

GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The present study will collect clinical data in the local target population as per the requirement of Korean Food and Drugs administration (FDA).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

First QC Date

October 12, 2005

Last Update Submit

October 15, 2008

Conditions

Hepatitis A

Interventions

Hepatitis ABIOLOGICAL

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. be reachable over the phone) should be enrolled in the study.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent is obtained from the subject/ subjects' parents or guardians.

You may not qualify if:

  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature \< 37.5°C (99.5°F) / Axillary temperature \< 37.5°C (99.5°F) / Rectal temperature \< 38°C (100.4°F) / Tympanic temperature on oral setting \< 37.5°C (99.5°F) / Tympanic temperature on rectal setting \< 38°C (100.4°F).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 13, 2005

Study Start

June 1, 2005

Last Updated

October 16, 2008

Record last verified: 2008-10