Clinical trial NCT01159925: Surveillance Study to Determine the Trends in Acute Hepatitis A Among Panamanian Children
Official title: Epidemiologic Surveillance to Assess Trends in Acute Hepatitis A Among Children in Panama
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hepatitis A
Hepatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subjects with confirmed diagnosis of non-viral hepatitis

Primary outcomes:
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
timeFrame: average time-frame: 2.5 years
Secondary outcomes:
measure: Occurrence of possible and probable cases of acute hepatitis A virus by age group, area of residence and year of surveillance
timeFrame: average time-frame: 2.5 years
measure: Risk factors for confirmed cases of acute hepatitis A
timeFrame: average time-frame: 2.5 years
measure: Frequency of different clinical signs and symptoms of hepatitis A
timeFrame: average time-frame: 2.5 years
Other outcomes:
Locations:
city: Clayton
country: Panama
facility: GSK Investigational Site
state: Panamá
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.