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 (NCT) | NCT01405677 |
| Protocol serial number | EPA 001 FU |
| Sponsor | Berna Biotech AG, a Crucell Company (Switzerland) |
| Funder | Berna Biotech AG, a Crucell Company (Swtizerland) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Follow up to an open, randomised, controlled trial (EPA 001) |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | EPA |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Epaxal® |
| Primary outcome measure(s) |
Proportion of subjects seroprotected five years after booster vaccination |
| Key secondary outcome measure(s) |
Individual antibody titres and Geometric Mean antibody Titres (GMTs) one, two, three, four, and five years after booster vaccination. |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target sample size at registration | 308 |
| Total final enrolment | 271 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/03/2011 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Centre for the Evaluation of Vaccination
Antwerp
2610
Belgium
2610
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
