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Euvax B: Hepatitis B vaccine

Phase 3

Hepatitis B | Vaccine | Infectious Disease |Sanofi|Last Updated: Apr 6, 2022

Target and mechanism

ModalityVaccine

Also known as Euvax B®: Hepatitis B vaccine

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Euvax B: Hepatitis B vaccine · 1 trial · 1 indication

Phase 3 1
NCT02697474Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.Hepatitis B
COMPLETED150 Analytics
PHASE3COMPLETED
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Day 0 (pre-vaccination)
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine
Day 28 (post-vaccination)

Secondary Endpoints

Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
Day 0 up to Day 28 post-vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Hexaxim® GroupEXPERIMENTALSubjects that received Hexaxim® in Study A3L12
Infanrix® hexa GroupEXPERIMENTALSubjects that received Infanrix® hexa in Study A3L12

Interventions

NameTypeDescription
Euvax B®: Hepatitis B vaccineBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range9 Years to 10 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Informed consent form signed by subject's parent/legally acceptable representative * Assent form signed by subject * Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures * Receipt of primary vaccin...

Countries:Thailand
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Frequently asked questions about Euvax B: Hepatitis B vaccine

What is Euvax B used for?

Euvax B is a hepatitis B vaccine used to prevent hepatitis B infection. It is a vaccine in the infectious disease therapeutic area, developed by Sanofi. The vaccine is given to stimulate immune protection against the hepatitis B virus, and it has been studied in a Phase 3 clinical trial in Thailand.

Who makes Euvax B?

Euvax B is made by Sanofi, which trades under the ticker SNY. Sanofi develops and manufactures the hepatitis B vaccine. The product is also written as Euvax B® with the registered trademark symbol.

What phase is Euvax B in?

Euvax B has been evaluated in a Phase 3 clinical trial, and that trial is completed. The program has one completed Phase 3 study with no active trials listed. The available record does not indicate that Euvax B is approved by the FDA, so it should be regarded as a vaccine candidate in clinical development.

What clinical trials is Euvax B in?

Euvax B was studied in the Phase 3 trial NCT02697474, titled Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine. The trial enrolled 150 participants in Thailand, included healthy volunteers of all sexes from age 9 years, and is completed.

Is Euvax B the same as Euvax B®?

Yes, Euvax B and Euvax B® refer to the same hepatitis B vaccine from Sanofi. The ® symbol simply marks the registered trademark version of the name. Both names identify the same vaccine product studied in the Phase 3 trial NCT02697474 for hepatitis B.

What is Euvax B used for in hepatitis B?

Euvax B is used for prevention of hepatitis B, an infectious disease of the liver. It is a vaccine modality developed by Sanofi. Its Phase 3 trial NCT02697474 assessed anti-hepatitis B antibodies at age 9 to 10 years after hepatitis B vaccination at birth and a DTaP-IPV-Hep B-PRP-T hexavalent vaccine.