Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA

Study Overview
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Brief Summary
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To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.

Official Title
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An Open-label, Controlled, Multi-centre Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO to Explore the Anamnestic Immune Response in Healthy Children Vaccinated 10 Years Ago With a Primary Series (3 Doses) of Either HEXAVAC or INFANRIX HEXA

Conditions
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Virus Diseases, Hepatitis B

Intervention / Treatment
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* Biological: HBVAXPRO 5µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy child Child vaccinated with 3 doses of HEXAVAC or 3 doses of INFANRIX HEXA as infant Child vaccinated with the third dose of HEXAVAC or INFANRIX HEXA at least 10 years prior to challenge dose Exclusion Criteria: Receipt of more than 3 doses of any Hepatitis B containing vaccine History of clinical diagnosis of infection due to Hepatitis B History or current close contact with known carriers of Hepatitis B virus Prior known sensitivity or allergy to any component of HBVAXPRO Chronic illness / medical condition that could interfere with study conduct or completion Coagulation disorder that would contraindicate intramuscular injection Subject is pregnant Receipt of corticosteroids for more than 14 days in the 30 days prior to study Receipt of Immunoglobulins, blood or blood-derived products in the 3 months prior to study Planned participation in another clinical study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBVAXPRO Challenge dose<br>HBVAXPRO 5µg | Biological: HBVAXPRO 5µg<br>* 0.5mL intramuscular injection<br>* Other names: Hepatitis B vaccine (rDNA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL |  | One month after the challenge dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with an anti-hepatitis B concentration ≥10 mIU/mL |  | Prior to challenge dose (At Day 0 prior to administration of the challenge dose) | 
| Solicited injection-site adverse reactions and pyrexia |  | Day 0 to day 4 after vaccination | 
| Unsolicited injection-site adverse reactions and systemic adverse events |  | Day 0 to day 14 after vaccination | 
| Serious adverse events |  | From signature of the informed consent to the last visit of the subject, an expected average of one month |