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Home > Protocol Summaries: Compounds > Hepatitis A Vaccine, Inactivated > Protocol Summary for 112158

Protocol Summary for 112158

Protocol Summary
Protocol Id: 112158
Secondary Ids:
  • N/A
Title: Epidemiologic surveillance to assess trends in acute hepatitis A among children in Panama
Phase: n\a
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • Panama: Ministerio de Salud
Collaborators:
  • N/A
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.
Record Verification Date: November 2012
Status: Completed
Why Study Stopped:
Study Start Date: July 2009
Study Completion Date: December 2011
Study Completion Date Type: Actual
Primary Completion Date: December 2011
Primary Completion Date Type: Actual
Study Design: Case-Only
Time Perspective: Prospective
Biospecimen Retention: Samples with DNA
Biospecimen Description: Serum
Primary Outcomes:
  • 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
Secondary Outcomes:
  • Frequency of different clinical signs and symptoms of hepatitis A average time-frame: 2.5 years
  • 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
Conditions:
  • Acute hepatitis A
  • Hepatitis
Keywords:
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
Sampling Method: Probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 1 Months
Maximum Age: 15 Year
Enrollment: 42
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information