Condition category
Infections and Infestations
Date applied
21/11/2006
Date assigned
14/12/2006
Last edited
14/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.crucell.com/

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

Publication citations

Additional files

Editorial Notes