Hepatitis ANCT00237991
Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population
An observational study of Hepatitis A, run by GlaxoSmithKline.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A
- What is being tested?
- Hepatitis A
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.
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).
Read the detailed description
All subjects will be administered one dose of the hepatitis A vaccine.
- Conditions
- Hepatitis A
- Being tested
- Hepatitis A
- Medical subject headings
- Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis ABiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237991
- Sponsor's protocol ID
- 104147
- Status last verified
- Oct 2008
- First submitted
- 12 Oct 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.
- ClinicalTrials.gov ID
- NCT00237991
- Acronym / sponsor ID
- 104147
- Conditions
- Hepatitis A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 13 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
All subjects will be administered one dose of the hepatitis A vaccine.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis A | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis A, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2008.