A long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule

ISRCTN ISRCTN17386851
DOI https://doi.org/10.1186/ISRCTN17386851
ClinicalTrials.gov number NCT01405677
Secondary identifying numbers EPA 001 FU
Submission date
21/11/2006
Registration date
14/12/2006
Last edited
05/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Pierre Van Damme, MD
Scientific

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

Study information

Study designFollow up to an open, randomised, controlled trial (EPA 001)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleA long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule
Study acronymEPA
Study objectivesThe 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(s)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]).
Health condition(s) or problem(s) studiedHepatitis A
InterventionInterventions 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Epaxal®
Primary outcome measureProportion of subjects seroprotected five years after booster vaccination
Secondary outcome measuresIndividual antibody titres and Geometric Mean antibody Titres (GMTs) one, two, three, four, and five years after booster vaccination.
Overall study start date01/12/2006
Completion date01/03/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Months
Upper age limit16 Years
SexNot Specified
Target number of participants308
Total final enrolment271
Key inclusion criteria1. 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
Key exclusion criteria1. Subjects NOT enrolled and randomised in the primary study (EPA 001)
2. Subjects NOT having received two doses of the study vaccines
Date of first enrolment01/12/2006
Date of final enrolment01/03/2011

Locations

Countries of recruitment

  • Belgium

Study participating centre

Centre for the Evaluation of Vaccination
Antwerp
2610
Belgium

Sponsor information

Berna Biotech AG, a Crucell Company (Switzerland)
Industry

c/o Christian Herzog, MD
Rehhagstrasse 79
Bern
3018
Switzerland

Website http://www.crucell.com/

Funders

Funder type

Industry

Berna Biotech AG, a Crucell Company (Swtizerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2015 05/01/2021 Yes No

Editorial Notes

05/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT number has been added.