Hepatitis A
Conditions
Keywords
Hepatitis A Vaccine, Combined Vaccines, DTP Vaccine, MMR Vaccine
Brief summary
The primary purpose of this study was to assess whether the protection afforded by Epaxal vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain information on the long term protection afforded by Epaxal, and to compare this with an alternative hepatitis A vaccine (Havrix).
Interventions
BIOLOGICALEpaxal
0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
BIOLOGICALHavrix 720
0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
Sponsors
Crucell Holland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
Original study: * Written informed consent obtained from the parent/legal guardian of the subject. * Free of obvious health problems as established by medical history and/or clinical examination before entering the study. * At least 8 kg of body weight at age of 12 months. Follow-up phase: * Subjects enrolled and randomised in the original study and having received two doses of the hepatitis A study vaccines.
Exclusion criteria
Original study: * Children not having received 3 documented doses of DTPaHib and polio vaccines during infancy * Children having received a documented dose of MMR during infancy * Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Administration of systemic corticosteroids (inhaled and topical steroids are allowed). * Administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine. * Previous vaccination against hepatitis A. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness * Acute disease at the time of enrolment. Follow-up phase: * Children who had received a hepatitis A antigen containing vaccine since the last visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-hepatitis A virus (HAV) antibody concentrations | 5.5 years | Individual anti-HAV antibody concentrations determined by enzyme-linked immunosorbent assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean concentrations (GMC) | 5.5 and 7.5 years | GMCs of anti-HAV antibodies |
| Proportion of seroprotected subjects | 5.5 and 7.5 years | Proportion of subjects seroprotected defined as anti-HAV antibody concentrations of at least 10 mIU/ml |
Countries
Israel
Outcome results
None listed