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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01159925
Other study ID # 112158
Secondary ID
Status Completed
Phase N/A
First received July 8, 2010
Last updated November 21, 2012
Start date July 2009
Est. completion date December 2011

Study information

Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Panama: Ministerio de Salud
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 15 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Serum sample
Serum samples collected

Locations

Country Name City State
Panama GSK Investigational Site Clayton Panamá

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Risk factors for confirmed cases of acute hepatitis A average time-frame: 2.5 years No
Secondary Frequency of different clinical signs and symptoms of hepatitis A average time-frame: 2.5 years No
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