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As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A vaccine AVAXIM 80U | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine | 1 month post-vaccination |
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Inclusion Criteria :
Inclusion criteria to be checked at the screening visit (SC):
Toddlers, children and adolescents:
Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
Sub-Group 2: from 4 to 6 years of age on the day of inclusion
Sub-Group 3: from 7 to 9 years of age on the day of inclusion
Sub-Group 4: from 10 to 12 years of age on the day of inclusion
Sub-Group 5: from 13 to 15 years of age on the day of inclusion
Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
Inclusion criteria to be checked at the inclusion visit (V01):
Toddlers, children and adolescents:
Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
Sub-Group 2: from 4 to 6 years of age on the day of inclusion
Sub-Group 3: from 7 to 9 years of age on the day of inclusion
Sub-Group 4: from 10 to 12 years of age on the day of inclusion
Sub-Group 5: from 13 to 15 years of age on the day of inclusion
Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
Able to attend all scheduled visits and to comply with all trial procedures
Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
Subject HBsAg seronegative and ALT <40 IU/l according to the screening results
Exclusion Criteria :
Exclusion criteria to be checked at the inclusion visit (V01):
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guilin | Guangxi | 541001 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26770041 | Derived | Yoon SH, Kim HW, Ahn JG, Kim IT, Kim JH, Kong KA, Kim KH. Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents. J Korean Med Sci. 2016 Jan;31(1):73-9. doi: 10.3346/jkms.2016.31.1.73. Epub 2015 Dec 24. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Hepatitis A vaccine (HAVRIX 720) | Biological | 0.5 mL, Intramuscular |
|
| Nanning |
| Guangxi |
| 530021 |
| China |
| Yongfu Country | Guangxi | 541800 | China |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |