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HBVAXPRO 5µg

Phase 3

Virus Diseases | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 11, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment751

FDA Designations

No designations recorded

Clinical trial landscape

HBVAXPRO 5µg · 1 trial · 2 indications

Phase 3 1
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
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

Study Endpoints

Primary Endpoints

Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL
One month after the challenge dose

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

Interventions

NameTypeDescription
HBVAXPRO 5µgBIOLOGICAL0.5mL intramuscular injection
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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 vaccine used for Hepatitis B and virus diseases. It is being developed by Sanofi for the prevention of Hepatitis B infection. The vaccine is currently in Phase 3 clinical development and is intended for use in healthy children to assess immune response after primary vaccination.

Who makes HBVAXPRO 5µg?

HBVAXPRO 5µg is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in pediatric populations.

What phase is HBVAXPRO 5µg in?

HBVAXPRO 5µg is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are completed and focused on assessing immune responses in healthy children.

What clinical trials is HBVAXPRO 5µg in?

HBVAXPRO 5µg has been studied in two completed Phase 3 trials. NCT00693186 assessed anamnestic immune response in children aged 4 to 7 years after primary vaccination with HEXAVAC or INFANRIX-HEXA. NCT02012998 evaluated immunogenicity and safety of a challenge dose in children vaccinated 10 years earlier.

Is HBVAXPRO 5µg the same as HEXAVAC or INFANRIX-HEXA?

No, HBVAXPRO 5µg is not the same as HEXAVAC or INFANRIX-HEXA. HBVAXPRO is a separate vaccine developed by Sanofi. The clinical trials compare immune responses in children who received primary vaccination with HEXAVAC or INFANRIX-HEXA, followed by a challenge dose of HBVAXPRO.