Last updated: 11/07/2018 04:27:26
Surveillance study to determine the trends in acute hepatitis A among Panamanian children
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Epidemiologic surveillance to assess trends in acute hepatitis A among children in Panama
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
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
Timeframe: average time-frame: 2.5 years
Secondary outcomes:
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
Risk factors for confirmed cases of acute hepatitis A
Timeframe: average time-frame: 2.5 years
Frequency of different clinical signs and symptoms of hepatitis A
Timeframe: average time-frame: 2.5 years
Interventions:
Procedure/surgery: Serum sample
Enrollment:
42
Observational study model:
Case-Only
Primary completion date:
2011-30-12
Time perspective:
Prospective
Clinical publications:
Estripeaut D et al. (2015) Impact of Hepatitis A vaccination with a two-dose schedule in Panama: Results of epidemiological surveillance and time trend analysis. Vaccine. 33(28):3200-3207.
Medical condition
Acute hepatitis A
Product
SB208109
Collaborators
Not applicable
Study date(s)
July 2009 to December 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
1 months - 15 years
Accepts healthy volunteers
No
- 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.
- Subjects with confirmed diagnosis of non-viral hepatitis
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
Subjects with confirmed diagnosis of non-viral hepatitis
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2011-30-12
Actual study completion date
2011-30-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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