Acute Hepatitis ANCT01159925
Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children
An observational study of Acute Hepatitis A and Hepatitis, run by GlaxoSmithKline at 1 site in Panama.
Trial summary
The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Acute Hepatitis A, Hepatitis
- What is being tested?
- Serum sample
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 sitePanama
- Study dates
- Jul 2009to Dec 2011
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged >1 month and <15 years of age being seen for possible acute hepatitis A during the study time period at the selected sentinel hospitals of Panama
Who may be able to join
- A male or female between >1 month and <15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
- Subjects with clinical diagnosis of possible acute hepatitis A.
- Written informed consent obtained from the parent or guardian of the subject.
- Subjects for whom a blood sample is collected.
Who cannot join
- Subjects with confirmed diagnosis of non-viral hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama
The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization.
Read the detailed description
This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in Panama. Hospitals are selected based on population density or hepatitis A disease burden.
The Pan American Health Organization (PAHO) definition for a possible case of acute hepatitis A are used for subjects aged between >1 month and <15 years.
Data regarding clinical and epidemiologic information are collected and serum samples are collected to test hepatitis A markers and determine if infection with hepatitis A virus has recently occurred.
Surveillance will be for a period of approximately 2.5 years from the date of study initiation.
- Conditions
- Acute Hepatitis A, Hepatitis
- Being tested
- Serum sample
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum sampleProcedure or surgery
Serum samples collected
| Study group | Role | What they receive |
|---|---|---|
| Possible hepatitis A Cohort | Children with an acute disease characterized by discrete onset of symptoms and jaundice Receives: Procedure: Serum sample | |
| Probable hepatitis A Cohort | Children with an increase in serum levels of transaminase 2.5 times higher than the maximum limit of the normal interval Receives: Procedure: Serum sample | |
| Confirmed hepatitis A Cohort | Children presenting a positive result for Immunoglobulin M for hepatitis A virus Receives: Procedure: Serum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance
Measured: average time-frame: 2.5 years
Secondary outcomes (3)
Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance
Measured: average time-frame: 2.5 years
Risk factors for confirmed cases of acute hepatitis A
Measured: average time-frame: 2.5 years
Frequency of different clinical signs and symptoms of hepatitis A
Measured: average time-frame: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159925
- Sponsor's protocol ID
- 112158
- Status last verified
- Nov 2012
- First submitted
- 8 Jul 2010
- Last updated
- 22 Nov 2012
- Results posted
- No
Publications
Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.
PubMed 25981490
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama
- ClinicalTrials.gov ID
- NCT01159925
- Acronym / sponsor ID
- 112158
- Conditions
- Acute Hepatitis A, Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jul 2010 (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.
The purpose of this study is to collect epidemiological and clinical data to assess the vaccine impact and occurrence of confirmed acute hepatitis A cases in sentinel hospitals after the introduction of Havrix™ into the Expanded Program of Immunization.
Detailed description
This is an observational, prospective, multi-centre, sentinel based study in 3 hospitals in Panama. Hospitals are selected based on population density or hepatitis A disease burden.
The Pan American Health Organization (PAHO) definition for a possible case of acute hepatitis A are used for subjects aged between >1 month and <15 years.
Data regarding clinical and epidemiologic information are collected and serum samples are collected to test hepatitis A markers and determine if infection with hepatitis A virus has recently occurred.
Surveillance will be for a period of approximately 2.5 years from the date of study initiation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Possible hepatitis A Cohort | – | Procedure: Serum sampleChildren with an acute disease characterized by discrete onset of symptoms and jaundice |
| Probable hepatitis A Cohort | – | Procedure: Serum sampleChildren with an increase in serum levels of transaminase 2.5 times higher than the maximum limit of the normal interval |
| Confirmed hepatitis A Cohort | – | Procedure: Serum sampleChildren presenting a positive result for Immunoglobulin M for hepatitis A virus |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged >1 month and <15 years of age being seen for possible acute hepatitis A during the study time period at the selected sentinel hospitals of Panama
Key inclusion criteria (4 listed)
- A male or female between >1 month and <15 years of age at the time of enrolment, being referred to any of the 3 participating sentinel hospitals.
- Subjects with clinical diagnosis of possible acute hepatitis A.
- Written informed consent obtained from the parent or guardian of the subject.
- Subjects for whom a blood sample is collected.
Key exclusion criteria (1 listed)
- Subjects with confirmed diagnosis of non-viral hepatitis
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 |
|---|---|---|
| Serum sampleSerum samples collected | Procedure or surgery | Confirmed hepatitis A Cohort, Possible hepatitis A Cohort, Probable hepatitis A Cohort |
Primary outcome
Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance
Time frame: average time-frame: 2.5 years
3 secondary outcomes
Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance
Time frame: average time-frame: 2.5 years
Risk factors for confirmed cases of acute hepatitis A
Time frame: average time-frame: 2.5 years
Frequency of different clinical signs and symptoms of hepatitis A
Time frame: average time-frame: 2.5 years
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 22 Nov 2012.
- Derived from this study: PubMed 25981490Estripeaut D, Contreras R, Tinajeros O, Castrejon MM, Shafi F, Ortega-Barria E, DeAntonio R. Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 2015 Jun 22;33(28):3200-7. doi: 10.1016/j.vaccine.2015.04.100. Epub 2015 May 14.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hepatitis A and Hepatitis, run by GlaxoSmithKline at 1 site in Panama.
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 4 inclusion and 1 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 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Occurrence of confirmed acute hepatitis A cases identified in the selected sentinel hospitals during the study period by age group, area of residence and year of surveillance (time frame: average time-frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159925, which also lists 1 linked publication.
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 22 Nov 2012; AzTrials last refreshed its copy on 6 Nov 2026.