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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001602-28 | EudraCT Number |
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To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBVAXPRO Challenge dose | Experimental | HBVAXPRO 5µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBVAXPRO 5µg | Biological | 0.5mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL | One month after the challenge dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL | Prior to challenge dose (At Day 0 prior to administration of the challenge dose) | |
| Solicited injection-site adverse reactions and pyrexia | Day 0 to day 4 after vaccination |
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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 |
|---|---|---|---|---|---|---|
| Sanofi Pasteur MSD Investigational Site 004 | Bologna | Italy | ||||
| Sanofi Pasteur MSD Investigational Site 009 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28624307 | Derived | Zanetti A, Desole MG, Romano L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16. |
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| Unsolicited injection-site adverse reactions and systemic adverse events | Day 0 to day 14 after vaccination |
| Serious adverse events | From signature of the informed consent to the last visit of the subject, an expected average of one month |
| Cagliari |
| Italy |
| Sanofi Pasteur MSD Investigational Site 005 | Capannori | Italy |
| Sanofi Pasteur MSD Investigational Site 003 | Chiavari | Italy |
| Sanofi Pasteur MSD Investigational Site 002 | Latisana | Italy |
| Sanofi Pasteur MSD Investigational Site 008 | Massafra | Italy |
| Sanofi Pasteur MSD Investigational Site 006 | Nocera Inferiore | Italy |
| Sanofi Pasteur MSD Investigational Site 010 | Ragusa | Italy |
| Sanofi Pasteur MSD Investigational Site 007 | Salerno | Italy |
| Sanofi Pasteur MSD Investigational Site 001 | Sassari | Italy |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| D004275 | DNA, Ribosomal |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004247 | DNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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