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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sanofi Pasteur MSD
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT02012998
First received: December 11, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Virus Diseases
Hepatitis B
Biological: HBVAXPRO 5µg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL [ Time Frame: One month after the challenge dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Solicited injection-site adverse reactions and pyrexia [ Time Frame: Day 0 to day 4 after vaccination ] [ Designated as safety issue: Yes ]
  • Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: Day 0 to day 14 after vaccination ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of one month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: January 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBVAXPRO Challenge dose
HBVAXPRO 5µg
Biological: HBVAXPRO 5µg
0.5mL intramuscular injection
Other Name: Hepatitis B vaccine (rDNA)

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012998

Contacts
Contact: Florence BOISNARD, PhD clinicaldevelopment@spmsd.com
Contact: Marie WEHRLEN-GRANDJEAN, MD clinicaldevelopment@spmsd.com

Locations
Italy
Sanofi Pasteur MSD Investigational Site 004 Not yet recruiting
Bologna, Italy
Sanofi Pasteur MSD Investigational Site 009 Not yet recruiting
Cagliari, Italy
Sanofi Pasteur MSD Investigational Site 005 Recruiting
Capannori, Italy
Sanofi Pasteur MSD Investigational Site 003 Recruiting
Chiavari, Italy
Sanofi Pasteur MSD Investigational Site 002 Recruiting
Latisana, Italy
Sanofi Pasteur MSD Investigational Site 008 Recruiting
Massafra, Italy
Sanofi Pasteur MSD Investigational Site 006 Recruiting
Nocera Inferiore, Italy
Sanofi Pasteur MSD Investigational Site 010 Recruiting
Ragusa, Italy
Sanofi Pasteur MSD Investigational Site 007 Recruiting
Salerno, Italy
Sanofi Pasteur MSD Investigational Site 001 Recruiting
Sassari, Italy
Sponsors and Collaborators
Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT02012998     History of Changes
Other Study ID Numbers: HXV02C, 2013-001602-28
Study First Received: December 11, 2013
Last Updated: June 3, 2014
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on July 22, 2014