A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00693186
First received: June 4, 2008
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

Primary objective:

  • To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a booster dose of either HBVaxPRO® 5 µg or Engerix B® 10 µg .

Secondary objectives:

  • Additional immunogenicity assessments
  • Standard safety assessment.

Condition Intervention Phase
Hepatitis B
Biological: HBVaxPRO® 5 µg / 0.5 mL
Biological: Engerix B® 10 µg / 0.5 mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label, Randomised, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Booster Dose of Two Different Hepatitis B Vaccines to Explore the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children Previously Vaccinated at About 3, 5 and 11 to 13 Months of Age With 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 anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose [ Time Frame: 28 to 42 days ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: HBVaxPRO® 5 µg / 0.5 mL
5 µg / 0.5 mL
Experimental: 2 Biological: Engerix B® 10 µg / 0.5 mL
10 µg

  Eligibility

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy child of 4 to 7 years of age of either gender,
  • Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 months of life and with a 3rd dose of INFANRIX®-HEXA before the end of the second year of life,
  • Informed consent form signed by the parent(s) or by the legal representative.
  • Parent(s) or legal representative able to understand and comply with the study procedures.

Exclusion Criteria:

  • Any recent (<=3 days) history of febrile illness prior to vaccination,
  • Receipt of more than 3 doses of any Hepatitis B containing vaccine, either alone or in any combination,
  • History of clinical or serological-confirmed diagnosis of infection due to hepatitis B,
  • History or current close contact with known carriers of hepatitis B virus,
  • Prior known sensitivity/allergy to any component of the study vaccines,
  • Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
  • Any immune impairment or humoral/cellular deficiency or depressed immunity,
  • Any recent (<=30 days) long-term (>=14 days) administration of systemic corticosteroids given daily or on alternate days at >=20 mg/day prednisone equivalent or scheduled administration through Visit 2,
  • Any receipt (<=3 months) of immunoglobulins or blood-derived products, or scheduled administration through Visit 2,
  • Any recent (<=14 days) receipt of an inactivated vaccine or scheduled administration through Visit 2,
  • Any recent (<=28 days) receipt of a live vaccine or scheduled administration through Visit 2
  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: NCT00693186

Locations
Italy
Unità Operativa Semplice di Epidemiologia (UOSE)
Quarto, Napoli, Italy
Azienda per i Servizi Sanitari n. 5 "Bassa Friulana"
Latisana, Udine, Italy
Ospedale Maggiore di Modica - Via Resistenza Partigiana (c/o Ospedale Maggiore)
Modica, Italy, 97015
AUSL n. 7 di Ragusa Servizio di Epidemiologia Via G. Di Vittorio 59/c
Ragusa, Italy, 97100
Dipartimento di Prevenzione Servizio di Igiene Pubblica
Sassari, Italy
Sponsors and Collaborators
Sanofi Pasteur MSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00693186     History of Changes
Other Study ID Numbers: HXV01C
Study First Received: June 4, 2008
Last Updated: November 17, 2010
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on July 31, 2014