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HBVAXPRO 5µg

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |Sanofi|Trials Updated: Sep 11, 2017

HBVAXPRO 5µg development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Dec 2013

HBVAXPRO 5µg target and mechanism

ModalityMonoclonal antibody

Also known as Hepatitis B vaccine (rDNA)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment1,161

FDA Designations

No designations recorded

HBVAXPRO 5µg clinical trials

HBVAXPRO 5µg · 2 trials · 2 indications

Phase 3 2
NCT02012998Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXAVirus Diseases
COMPLETED751 Analytics
NCT00693186A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXAHepatitis B
COMPLETED410 Analytics
PHASE3COMPLETED
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
Virus DiseasesUnlock trial analytics
PHASE3COMPLETED
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
One month after the challenge dose
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
28 to 42 days

Secondary Endpoints

Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
Prior to challenge dose (At Day 0 prior to administration of the challenge dose)
Solicited injection-site adverse reactions and pyrexia
Day 0 to day 4 after vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Day 0 to day 14 after vaccination
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
HBVAXPRO Challenge doseEXPERIMENTALHBVAXPRO 5µg
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
HBVAXPRO 5µgBIOLOGICAL0.5mL intramuscular injection
HBVaxPRO® 5 µg / 0.5 mLBIOLOGICAL5 µg / 0.5 mL
Engerix B® 10 µg / 0.5 mLBIOLOGICAL10 µg
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Eligibility Criteria

Age Range10 Years to 12 Years
SexALL
Healthy VolunteersYes
Study Sites10

Inclusion Criteria: * Healthy child * Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant * Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose Exclusion Criteria: * Receipt of more than 3 doses of any Hepatitis B c...

Countries:Italy
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Frequently asked questions about HBVAXPRO 5µg

What is HBVAXPRO 5µg used for?

HBVAXPRO 5µg is a hepatitis B vaccine used to prevent hepatitis B virus infection. It is studied in children and is given as a challenge or booster dose to assess immune response in individuals previously vaccinated against hepatitis B. The drug is also referred to as HBVaxPRO 5 µg / 0.5 mL.

Who makes HBVAXPRO 5µg?

HBVAXPRO 5µg is developed and manufactured by Sanofi, which trades under the ticker SNY. Sanofi is a global pharmaceutical company that produces vaccines and other therapeutic products.

What phase is HBVAXPRO 5µg in?

HBVAXPRO 5µg is in Phase 3 clinical development. It is an investigational product and has been evaluated in completed Phase 3 trials. The development stage reflects ongoing clinical research rather than approved marketing status.

What clinical trials is HBVAXPRO 5µg in?

HBVAXPRO 5µg has been studied in completed Phase 3 trials including NCT02012998, which enrolled 751 healthy children in Italy, and NCT00693186, which enrolled 410 healthy children in Italy. Both trials assessed immune responses after prior vaccination with HEXAVAC or INFANRIX HEXA.