NCT00693186CompletedPhase 3
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
Sanofi Pasteur, a Sanofi Company5 sites in 1 country410 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 410
- Locations
- 5
- Primary Endpoint
- Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Intervention: HBVaxPRO® 5 µg / 0.5 mL (Biological)
2
Experimental
Intervention: Engerix B® 10 µg / 0.5 mL (Biological)
Outcomes
Primary Outcomes
Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose
Time Frame: 28 to 42 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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