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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

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ClinicalTrials.gov Identifier: NCT02012998
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Virus Diseases Hepatitis B Biological: HBVAXPRO 5µg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA
Actual Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HBVAXPRO Challenge dose
HBVAXPRO 5µg
Biological: HBVAXPRO 5µg
0.5mL intramuscular injection
Other Name: Hepatitis B vaccine (rDNA)



Primary Outcome Measures :
  1. Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL [ Time Frame: One month after the challenge dose ]

Secondary Outcome Measures :
  1. Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL [ Time Frame: Prior to challenge dose (At Day 0 prior to administration of the challenge dose) ]
  2. Solicited injection-site adverse reactions and pyrexia [ Time Frame: Day 0 to day 4 after vaccination ]
  3. Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: Day 0 to day 14 after vaccination ]
  4. Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of one month ]


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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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 or completion
  • 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 to study
  • Planned participation in another clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012998


Locations
Italy
Sanofi Pasteur MSD Investigational Site 004
Bologna, Italy
Sanofi Pasteur MSD Investigational Site 009
Cagliari, Italy
Sanofi Pasteur MSD Investigational Site 005
Capannori, Italy
Sanofi Pasteur MSD Investigational Site 003
Chiavari, Italy
Sanofi Pasteur MSD Investigational Site 002
Latisana, Italy
Sanofi Pasteur MSD Investigational Site 008
Massafra, Italy
Sanofi Pasteur MSD Investigational Site 006
Nocera Inferiore, Italy
Sanofi Pasteur MSD Investigational Site 010
Ragusa, Italy
Sanofi Pasteur MSD Investigational Site 007
Salerno, Italy
Sanofi Pasteur MSD Investigational Site 001
Sassari, Italy
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02012998     History of Changes
Other Study ID Numbers: HXV02C
2013-001602-28 ( EudraCT Number )
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hepatitis B
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases