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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Humberto Ibarra

ORCID ID

Contact details

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

EPA 006

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

Acronym

EPA

Study hypothesis

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.

Study design

Open, randomised, controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Treatment

Patient information sheet

Condition

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

Overall study end date

01/08/2007

Reason abandoned (if study stopped)

Participant inclusion criteria

Healthy children aged 12 months to 16 years inclusive.

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

Participant 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

Recruitment start date

01/11/2006

Recruitment end date

01/08/2007

Countries of recruitment

Chile

Study participating centre

Gastroenterólogo
Valdivia
6670172
Chile

Organisation

Berna Biotech AG (Switzerland)

Sponsor details

c/o Christian Herzog
MD
Berna Biotech Ltd
a Crucell Company
Rehhagstrasse 79
Bern
3018
Switzerland

Sponsor type

Industry

Website

http://www.bernabiotech.com/home/

Funder type

Industry

Funder name

Berna Biotech AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs