Contact information
Type
Scientific
Primary contact
Prof Pierre Van Damme, MD
ORCID ID
Contact details
Centre for the Evaluation of Vaccination
World Health Organization Collaborating Centre for Control and Prevention of Viral Hepatitis
Unit of Epidemiology and Social Medicine
University of Antwerp
Universiteitsplein 1
Antwerp
2610
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EPA 001 FU
Study information
Scientific title
Acronym
EPA
Study hypothesis
The long term protection conferred by the pediatric dose of Epaxal® (12 IU) is comparable to that conferred by the standard dose of Epaxal® (24 IU).
Ethics approval
Approval received by local ethics committees (Comite voor Medische Etiek, Universitair Ziekenhuis Antwerpen [21/09/2006] and the Commissie Medische Ethiek, Sint-Vincentiusziekenhuis, Antwerp [26/10/2006]).
Study design
Follow up to an open, randomised, controlled trial (EPA 001)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Hepatitis A
Intervention
Interventions made in the primary study (EPA 001):
1. 0.25 ml Epaxal (12 IU hepatitis A antigen)
2. 0.50 ml Epaxal (24 IU hepatitis A antigen)
3. Comparator vaccine
From each subject willing to participate in this follow up study we will obtain:
First yearly visit: informed consent and circa 5 ml of veinous blood.
Four remaining yearly visits: circa 5 ml of veinous blood.
For each sample of blood the anti-Hepatitis A Virus (HAV) antibody titres using an Enzyme-Linked ImmunoSorbent Assay (ELISA) wil be tested.
Computer modeling of long term protection.
Intervention type
Drug
Phase
Phase II
Drug names
Epaxal®
Primary outcome measures
Proportion of subjects seroprotected five years after booster vaccination
Secondary outcome measures
Individual antibody titres and Geometric Mean antibody Titres (GMTs) one, two, three, four, and five years after booster vaccination.
Overall trial start date
01/12/2006
Overall trial end date
01/03/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy children and adolescents
2. More than or equal to 12 months to 16 years of age
3. Enrolled and randomised in the primary study (EPA 001) and having received two doses of the study vaccines
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
308
Participant exclusion criteria
1. Subjects NOT enrolled and randomised in the primary study (EPA 001)
2. Subjects NOT having received two doses of the study vaccines
Recruitment start date
01/12/2006
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Belgium
Trial participating centre
Centre for the Evaluation of Vaccination
Antwerp
2610
Belgium
Sponsor information
Organisation
Berna Biotech AG, a Crucell Company (Switzerland)
Sponsor details
c/o Christian Herzog
MD
Rehhagstrasse 79
Bern
3018
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Berna Biotech AG, a Crucell Company (Swtizerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary