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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HBVaxPRO® 5 µg / 0.5 mL
* Biological: Engerix B® 10 µg / 0.5 mL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: HBVaxPRO® 5 µg / 0.5 mL<br>* 5 µg / 0.5 mL<br>|
| Experimental: 2<br> | Biological: Engerix B® 10 µg / 0.5 mL<br>* 10 µg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with anti-HBs antibody titres >=10 mIU/mL measured at 1 month post-booster dose |  | 28 to 42 days |