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Hepatitis A vaccine AVAXIM 80U

Phase 3

Hepatitis A | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 22, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment720

FDA Designations

No designations recorded

Clinical trial landscape

Hepatitis A vaccine AVAXIM 80U · 1 trial · 1 indication

Phase 3 1
NCT00483470Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster DoseHepatitis A
COMPLETED720 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
Hepatitis AUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
1 month post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Hepatitis A vaccine AVAXIM 80UBIOLOGICAL0.5 mL, Intramuscular
Hepatitis A vaccine (HAVRIX 720)BIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range12 Months to 15 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria : Inclusion criteria to be checked at the screening visit (SC): 1. 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 o...

Countries:China
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Frequently asked questions about Hepatitis A vaccine AVAXIM 80U

What is Hepatitis A vaccine AVAXIM 80U used for?

Hepatitis A vaccine AVAXIM 80U is used for the prevention of Hepatitis A infection. It is an investigational vaccine being developed by Sanofi for use in pediatric populations, specifically studied in children as young as 12 months of age.

Who makes Hepatitis A vaccine AVAXIM 80U?

Hepatitis A vaccine AVAXIM 80U is developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. The vaccine is being studied for the prevention of Hepatitis A.

What phase is Hepatitis A vaccine AVAXIM 80U in?

Hepatitis A vaccine AVAXIM 80U is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved for public use and is still undergoing clinical trials to evaluate its safety and immunogenicity.

What clinical trials is Hepatitis A vaccine AVAXIM 80U in?

Hepatitis A vaccine AVAXIM 80U has been studied in a Phase 3 clinical trial with the identifier NCT00483470. This completed trial, titled 'Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose,' enrolled 720 participants in China to evaluate the vaccine's safety and immune response.

Is Hepatitis A vaccine AVAXIM 80U a monoclonal antibody?

Hepatitis A vaccine AVAXIM 80U is classified as a monoclonal antibody modality, though it is being developed as a vaccine for the prevention of Hepatitis A. It is currently in Phase 3 clinical trials and is not yet approved for use.