Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Havrixâ„¢ into the Expanded Program of Immunization.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Possible hepatitis A Cohort | Children with an acute disease characterized by discrete onset of symptoms and jaundice |
| |
| 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 |
| |
| Confirmed hepatitis A Cohort | Children presenting a positive result for Immunoglobulin M for hepatitis A virus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum sample | Procedure | Serum samples collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | average time-frame: 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance | average time-frame: 2.5 years | |
| Risk factors for confirmed cases of acute hepatitis A | average time-frame: 2.5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Clayton | Provincia de Panamá | Panama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25981490 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum
| Frequency of different clinical signs and symptoms of hepatitis A | average time-frame: 2.5 years |