A Phase 3 interventional study of Hepatitis A vaccine AVAXIM 80U and Hepatitis A vaccine (HAVRIX 720) in Hepatitis A, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in China. Open to participants aged 12 Months to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 720 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
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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
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
Exclusion Criteria :
Exclusion criteria to be checked at the inclusion visit (V01):
Biological: Hepatitis A vaccine AVAXIM 80U
Biological: Hepatitis A vaccine (HAVRIX 720)
0.5 mL, Intramuscular
Also known as: AVAXIM 80U Pediatric vaccine
0.5 mL, Intramuscular
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
Time frame: 1 month post-vaccination
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company