A phase III 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 comparator vaccine in healthy children and adolescents (12 months to 16 years of age inclusive), using a 0/6 month schedule
| ISRCTN | ISRCTN91009479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91009479 |
| Secondary identifying numbers | EPA 006 |
- Submission date
- 25/10/2006
- Registration date
- 14/11/2006
- Last edited
- 06/01/2021
- 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
Dr Humberto Ibarra
Scientific
Scientific
Gastroenterólogo
Instituto de Medicina
Facultad de Medicina/Universidad Austral de Chile
Valdivia
6670172
Chile
Study information
| Study design | Open, randomised, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A phase III 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 comparator vaccine in healthy children and adolescents (12 months to 16 years of age inclusive), using a 0/6 month schedule |
| Study acronym | EPA |
| Study objectives | The pediatric dose of Epaxal (12 IU) is as immunogenic as the standard Epaxal® dose (24 IU). |
| Ethics approval(s) | The Scientific Ethics Committee of the Health Service of Valdivia, Chile (Comité Etico Cientifico, Servicio de Salud, Valdivia, Chile) Hospital Base on the 28 September 2006. |
| Health condition(s) or problem(s) studied | Hepatitis A Virus |
| Intervention | 1) 0.25 ml Epaxal (12 IU hepatitis A antigen) 2) 0.50 ml Epaxal (24 IU hepatitis A antigen) 3) Comparator vaccine |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Epaxal® |
| Primary outcome measure | Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody titre greater or equal to 10 mIU/mL) one month after vaccination |
| Secondary outcome measures | 1. Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody titre greater or equal to 10 mIU/mL) one month after booster vaccination. 2. Proportion of subjects with local and/or systemic adverse events after each vaccination. |
| Overall study start date | 01/11/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target number of participants | 360 |
| Total final enrolment | 360 |
| Key inclusion criteria | Healthy children aged 12 months to 16 years inclusive. |
| Key exclusion criteria | 1. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed) 2. Previous vaccination against Hepatitis A Virus (HAV) 3. Seropositive for anti-HAV antibodies (screening Enzyme-Linked Immuno-Sorbent Assay [ELISA]) 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Chile
Study participating centre
Gastroenterólogo
Valdivia
6670172
Chile
6670172
Chile
Sponsor information
Berna Biotech AG (Switzerland)
Industry
Industry
c/o Christian Herzog, MD
Berna Biotech Ltd, a Crucell Company
Rehhagstrasse 79
Bern
3018
Switzerland
| Website | http://www.bernabiotech.com/home/ |
|---|
Funders
Funder type
Industry
Berna Biotech AG (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 08/11/2011 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
