Condition category
Infections and Infestations
Date applied
25/10/2006
Date assigned
14/11/2006
Last edited
14/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Humberto Ibarra

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EPA 006

Study information

Scientific title

Acronym

EPA

Study hypothesis

The pediatric dose of Epaxal (12 IU) is as immunogenic as the standard Epaxal® dose (24 IU).

Ethics approval

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

Trial setting

Not specified

Trial 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

Phase

Phase III

Drug names

Epaxal®

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children aged 12 months to 16 years inclusive.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

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

Locations

Countries of recruitment

Chile

Trial participating centre

Gastroenterólogo
Valdivia
6670172
Chile

Sponsor information

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/

Funders

Funder type

Industry

Funder name

Berna Biotech AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes