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Primary objective:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBVaxPRO® 5 µg / 0.5 mL | Biological | 5 µg / 0.5 mL |
| |
| Engerix B® 10 µg / 0.5 mL |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose | 28 to 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unità Operativa Semplice di Epidemiologia (UOSE) | Quarto | Napoli | Italy | |||
| Azienda per i Servizi Sanitari n. 5 "Bassa Friulana" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22789511 | Derived | Zanetti A, Parlato A, Romano L, Desole MG, Ferrera G, Giurdanella F, Zuliani M, Richard P, Thomas S, Fiquet A. Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy. Vaccine. 2012 Aug 24;30(39):5770-5. doi: 10.1016/j.vaccine.2012.06.078. Epub 2012 Jul 9. |
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| Biological |
10 µg |
|
| Latisana |
| Udine |
| Italy |
| Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore) | Modica | 97015 | Italy |
| AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c | Ragusa | 97100 | Italy |
| Dipartimento di Prevenzione Servizio di Igiene Pubblica | Sassari | Italy |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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