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
| ISRCTN | ISRCTN82277382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82277382 |
| Secondary identifying numbers | EPA 004 |
- Submission date
- 31/01/2006
- Registration date
- 10/03/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ron Dagan
Scientific
Scientific
Pediatric Infectious Diseases Unit
Soroka University Medical Center
P O Box 151
Beer Sheva
84101
Israel
Study information
| Study design | Open, randomised, controlled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Study acronym | EPA |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 26/01/2006 |
Eligibility
| 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 |
| Key inclusion criteria | Healthy children between 12 and 15 months old at the time of vaccination |
| Key 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 |
| Date of first enrolment | 26/12/2004 |
| Date of final enrolment | 26/01/2006 |
Locations
Countries of recruitment
- Israel
Study participating centre
Pediatric Infectious Diseases Unit
Beer Sheva
84101
Israel
84101
Israel
Sponsor information
Berna Biotech Ltd (Switzerland)
Industry
Industry
Rehhagstrasse 79
Bern
CH-3018
Switzerland
Funders
Funder type
Industry
Berna Biotech Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
