NCT01159951

Brief Summary

The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

2.6 years

First QC Date

July 8, 2010

Last Update Submit

June 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis)

    In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007)

Secondary Outcomes (3)

  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year

    From year 2000 until year 2010

  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups

    From year 2000 until year 2010

  • Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region

    From year 2000 until year 2010

Study Arms (1)

Hepatitis Cohort

Subjects suffering with hepatitis

Other: Epidemiologic Surveillance System of the Ministry of Health of Panama

Interventions

Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama

Hepatitis Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The target population to be studied will be all subjects reported with hepatitis related outcomes to the Epidemiologic Surveillance System of the Ministry of Health of Panama, between 2000 and 2010.

You may qualify if:

  • Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Clayton, Provincia de Panamá, Panama

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: NONE RETAINED

No samples retained

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 12, 2010

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations