Clinical Trials Logo
  1. Home
  2. Hepatitis A
  3. NCT01353989
  4. Details
NCT01353989 Clinical Trial

Hepatitis A Vaccination in the Elderly

Hepatitis A Clinical Trial

Official title:
Hepatitis A Vaccination in the Elderly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01353989
Other study ID # Hepatitis A vaccination
Secondary ID
Status Completed
Phase N/A
First received June 21, 2010
Last updated June 27, 2016
Start date July 2010
Est. completion date July 2015

Study information
Verified date June 2016
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Exclusion Criteria:

- previous hep A vaccination

- known hepatitis A serology status

- immunodeficiency

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Rijnstate Hospital Arnhem

Sponsors (1)
Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary How fast do patients> 60 year reach protective anti-HAV levels after vaccination? 0, 1,2,3,4 weeks No
See also
  Status Clinical Trial Phase
Withdrawn NCT03445416 - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men N/A
Completed NCT01949857 - The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00139139 - A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A N/A
Completed NCT00197171 - Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine Phase 3
Completed NCT00139113 - Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children Phase 4
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4
Completed NCT00197002 - Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age Phase 3
Withdrawn NCT02605538 - Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively N/A
Completed NCT04638335 - What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
Completed NCT00197015 - Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children Phase 3
Active, not recruiting NCT06058416 - Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Phase 4
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT02002065 - The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children N/A
Completed NCT01865968 - Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults Phase 4
Terminated NCT00119743 - A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine Phase 3
Completed NCT01000324 - Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult Phase 4
Completed NCT00289731 - Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc Phase 4
Completed NCT02300792 - The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A Phase 2