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

Last updated: September 8, 2017
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Completed

Phase

3

Condition

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT02012998
HXV02C
2013-001602-28
  • Ages 10-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.

Eligibility Criteria

Inclusion

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 yearsprior to challenge dose

Exclusion

Exclusion Criteria:

  • Receipt of more than 3 doses of any Hepatitis B containing vaccine

  • History of clinical diagnosis of infection due to Hepatitis B

  • History or current close contact with known carriers of Hepatitis B virus

  • Prior known sensitivity or allergy to any component of HBVAXPRO

  • Chronic illness / medical condition that could interfere with study conduct orcompletion

  • Coagulation disorder that would contraindicate intramuscular injection

  • Subject is pregnant

  • Receipt of corticosteroids for more than 14 days in the 30 days prior to study

  • Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior tostudy

  • Planned participation in another clinical study

Study Design

Total Participants: 751
Study Start date:
January 01, 2014
Estimated Completion Date:
February 28, 2015

Connect with a study center

  • Sanofi Pasteur MSD Investigational Site 004

    Bologna,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 009

    Cagliari,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 005

    Capannori,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 003

    Chiavari,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 002

    Latisana,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 008

    Massafra,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 006

    Nocera Inferiore,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 010

    Ragusa,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 007

    Salerno,
    Italy

    Site Not Available

  • Sanofi Pasteur MSD Investigational Site 001

    Sassari,
    Italy

    Site Not Available

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