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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Engerix B® 10 µg / 0.5 mL; Biological: HBVaxPRO® 5 µg / 0.5 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693186

HXV01C

Details and patient eligibility

About

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.

Enrollment: 410 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: HBVaxPRO® 5 µg / 0.5 mL

2

Experimental group

Treatment:

Biological: Engerix B® 10 µg / 0.5 mL