MedDataX Logo

Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population

NCT ID: NCT00237991

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All subjects will be administered one dose of the hepatitis A vaccine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hepatitis A

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GSK

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

104147

Identifier Type: -

Identifier Source: org_study_id