NCT04638335

Brief Summary

Study to determine the proportion of travelers over the age of 60 years and travelers having lived in a tropical country for more than 5 years with anti-HAV antibodies. This will be done through a blood test. The investigators will then proceed with a short statistical analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

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

October 6, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

October 25, 2020

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the percentage of anti-HAV positive tests in the two groups will be calculated

    In the first groupe, the percentage of travelers over 60 years of age with a positive anti-HAV test will be calculated. In the second groupe, the percentage of travelers having lived for more than 5 years in a tropical country with a positive anti-HAV test will be calculated.

    through study completion, an average of 1 year

Study Arms (2)

travelers over the age of 60

blood sample taken to test the presence of Anti-HAV antibodies

Biological: Blood test

travelers having lived in a tropical country for more than 5 years

blood sample taken to test the presence of Anti-HAV antibodies

Biological: Blood test

Interventions

Blood testBIOLOGICAL

blood test for Anti-HAV antibodies

travelers having lived in a tropical country for more than 5 yearstravelers over the age of 60

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

travelers coming for a consultation at the Policlinique de Médecine Tropicale, voyages et vaccinations, Unisanté

You may qualify if:

  • people over 60 years old or travelers that have lived in a tropical country for at least 5 years who consult the travel clinic of Unisanté

You may not qualify if:

  • subjects who have not given their consent,
  • are younger than 5 years old,
  • are unable to participate for some reason,
  • have already been vaccinated against hepatitis A
  • have been injected with immunoglobulins in the past 2 months (half-life of GamaStan: 23 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Travel Clinic, Department of Ambulatory Care and Community Medicine, University Hospital of Lausanne, Switzerland

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hepatitis A

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Serge De vallière, MD,MSc

    Unisanté

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2020

First Posted

November 20, 2020

Study Start

October 6, 2019

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

All anonymized data will be shared.

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
The data will be shared within the year of completing the project and will be available for 2 years after first published.

Locations