Clinical Trials Directory

Trials / Completed

CompletedNCT01353989

Hepatitis A Vaccination in the Elderly

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Rijnstate Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available. Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls. Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28. Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.

Conditions

Timeline

Start date
2010-07-01
Primary completion
2015-07-01
Completion
2015-07-01
First posted
2011-05-16
Last updated
2016-06-28

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01353989. Inclusion in this directory is not an endorsement.