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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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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 .
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
Actual Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
4 Years to 7 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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