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
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