Condition category
Infections and Infestations
Date applied
31/01/2006
Date assigned
10/03/2006
Last edited
22/03/2006
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

Prof Ron Dagan

ORCID ID

Contact details

Pediatric Infectious Diseases Unit
Soroka University Medical Center
P O Box 151
Beer Sheva
84101
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EPA 004

Study information

Scientific title

Acronym

EPA

Study hypothesis

Epaxal® co-administered with Diphtheria Tetanus Petusis (DTP), activated haemophilus influenzae type B (aHib), Inactivated Polio Vaccine (IPV), Oral Poliovirus Vaccine (OPV) and Measles Mumps Rubella (MMR) vaccines is as immunogenic as when given alone

Ethics approval

Approved by the Helsinki Committee of the Pediatric Infectious Diseases Unit, Soroka University Medical Center, November 2004, reference number: 20040507

Study design

Open, randomised, controlled

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hepatitis A

Intervention

1. Epaxal® and concomitant administration of DTP, aHib, IPV, OPV and MMR vaccines
2. Epaxal® followed by DTP, aHib, IPV, OPV and MMR vaccines one month later
3. Comparator Hepatitis A Virus (HAV) vaccine and concomitant administration of HAV vaccines

Intervention type

Drug

Phase

Not Specified

Drug names

Vaccines:
1. Epaxal®
2. Diphtheria Tetanus Petusis (DTP)
3. Activated haemophilus influenzae type B (aHib)
4. Inactivated Polio Vaccine (IPV)
5. Oral Poliovirus Vaccine (OPV)
6. Measles Mumps Rubella (MMR)

Primary outcome measures

Percentage of subjects seroprotected (anti-HAV titre >/=10 mIU/ml) one month after vaccination

Secondary outcome measures

1. Percentage of subjects with antibodies against each co-administered antigen one month after vaccination
2. Incidence of adverse events reported after each vaccination

Overall trial start date

26/12/2004

Overall trial end date

26/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy children between 12 and 15 months old at the time of vaccination

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Children that have not received three documented doses of DTP, aHib and polio vaccines during infancy
2. Children that have received a documented dose of MMR during infancy
3. Previous vaccination against hepatitis A
4. Any confirmed or suspected immunosuppressive or immunodeficient condition

Recruitment start date

26/12/2004

Recruitment end date

26/01/2006

Locations

Countries of recruitment

Israel

Trial participating centre

Pediatric Infectious Diseases Unit
Beer Sheva
84101
Israel

Sponsor information

Organisation

Berna Biotech Ltd (Switzerland)

Sponsor details

Rehhagstrasse 79
Bern
CH-3018
Switzerland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Berna Biotech Ltd

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