Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
EPA 004
Study information
Scientific title
Safety and immunogenicity of concomitant administration of a virosomal hepatitis A vaccine (Epaxal®) with DTP, aHib, IPV, OPV and MMR vaccines versus non-concomitant administration in 12 to 15 month-old children
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(s)
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
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
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 measure
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 study start date
26/12/2004
Overall study end date
26/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy children between 12 and 15 months old at the time of vaccination
Participant type(s)
Patient
Age group
Child
Lower age limit
12 Months
Upper age limit
15 Months
Sex
Both
Target number of participants
300
Total final enrolment
322
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
Study 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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | 11/01/2021 | Yes | No |