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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 )

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 17, 2013
Last Update Posted Date September 11, 2017
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL [ Time Frame: One month after the challenge dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02012998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
  • 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) ]
  • Solicited injection-site adverse reactions and pyrexia [ Time Frame: Day 0 to day 4 after vaccination ]
  • Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: Day 0 to day 14 after vaccination ]
  • Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of one month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL [ Time Frame: Prior to challenge dose ]
  • Solicited injection-site adverse reactions and pyrexia [ Time Frame: Day 0 to day 4 after vaccination ]
  • Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: Day 0 to day 14 after vaccination ]
  • Serious adverse events [ Time Frame: From signature of the informed consent to the last visit of the subject, an expected average of one month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Virus Diseases
  • Hepatitis B
Intervention  ICMJE Biological: HBVAXPRO 5µg
0.5mL intramuscular injection
Other Name: Hepatitis B vaccine (rDNA)
Study Arms  ICMJE Experimental: HBVAXPRO Challenge dose
HBVAXPRO 5µg
Intervention: Biological: HBVAXPRO 5µg
Publications * Zanetti A, Desole MG, Romanò L, d'Alessandro A, Conversano M, Ferrera G, Panico MG, Tomasi A, Zoppi G, Zuliani M, Thomas S, Soubeyrand B, Eymin C, Lockhart S. Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy. Vaccine. 2017 Jul 13;35(32):4034-4040. doi: 10.1016/j.vaccine.2017.05.047. Epub 2017 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
751
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2013)
750
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02012998
Other Study ID Numbers  ICMJE HXV02C
2013-001602-28 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP