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
Protocol serial number	EPA 006
Sponsor	Berna Biotech AG (Switzerland)
Funder	Berna Biotech AG (Switzerland)

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

Gastroenterólogo
Instituto de Medicina
Facultad de Medicina/Universidad Austral de Chile
Valdivia
6670172
Chile

Study information

Primary study design	Interventional
Study design	Open, randomised, controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Epaxal®
Primary outcome measure(s)	Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody titre greater or equal to 10 mIU/mL) one month after vaccination
Key secondary outcome measure(s)	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.
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 sample size at registration	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

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	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.