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Hepatitis A vaccine AVAXIM 80U

Phase 3

Hepatitis A | Vaccine | Infectious Disease |Sanofi|Trials Updated: Jan 22, 2014

Hepatitis A vaccine AVAXIM 80U development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2007

Hepatitis A vaccine AVAXIM 80U target and mechanism

ModalityVaccine

Also known as AVAXIM 80U Pediatric vaccine

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

Hepatitis A vaccine AVAXIM 80U clinical trials

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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Competitive Landscape -Hepatitis B 40 trials (matched to "Hepatitis A")

Frequently asked questions about Hepatitis A vaccine AVAXIM 80U

What is AVAXIM 80U used for?

AVAXIM 80U is a vaccine developed by Sanofi for the prevention of hepatitis A. It is a pediatric formulation intended for use in children, with clinical study enrollment beginning at 12 months of age. The vaccine is designed to protect against hepatitis A virus infection.

Who makes AVAXIM 80U?

AVAXIM 80U is made by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The vaccine is part of Sanofi's hepatitis A vaccine portfolio.

What phase is AVAXIM 80U in?

AVAXIM 80U has been studied in a Phase 3 clinical trial. The trial has been completed. The vaccine is an investigational product in the context of this trial, and the data describe a completed Phase 3 study rather than a marketed product.

What clinical trials is AVAXIM 80U in?

AVAXIM 80U has been evaluated in one clinical trial, NCT00483470, titled Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose. The trial was a completed Phase 3 study with 720 participants, conducted in China, and used an active-controlled, randomized design.

What is the AVAXIM 80U pediatric vaccine?

The AVAXIM 80U pediatric vaccine is a hepatitis A vaccine developed by Sanofi. It was tested in a Phase 3 trial in China involving 720 children from 12 months of age. The study assessed immunogenicity and safety, followed by a booster dose.