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The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epaxal 0.25 mL | Experimental | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
|
| Epaxal 0.5 mL | Active Comparator | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
|
| Havrix Junior | Active Comparator | Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epaxal 0.25 mL | Biological | 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual anti-HAV titers | Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection | 66 months post-booster |
| Individual anti-HAV titers | Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection | 18 months post-booster |
| Individual anti-HAV titers | Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection | 30 months post-booster |
| Individual anti-HAV titers | Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection | 42 months post-booster |
| Individual anti-HAV titers | Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection | 54 months post-booster |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers | 18, 30, 42, 54, 66 months post-booster | |
| Seroprotection | Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL |
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Inclusion Criteria:
Original study:
Follow up phase:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre van Damme, MD | Universiteit Antwerpen | Principal Investigator |
| Andre Vertruyen, MD | Sint-Vincentiusziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint-Vincentiusziekenhuis | Antwerp | B-2018 | Belgium | |||
| Centre for the Evaluation of Vaccination, University of Antwerp |
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| ID | Term |
|---|---|
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| C530970 | epaxal berna |
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| Epaxal 0.5 mL | Biological | 24 IU hepatitis A antigen coupled to IRIV |
|
| Havrix Junior 0.5 mL | Biological | 720 EU hepatitis A antigen absorbed onto aluminum hydroxide |
|
| 18, 30, 42, 54, 66 months post-booster |
| Antwerp |
| BE-2610 |
| Belgium |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |