Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

Study Overview
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Brief Summary
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The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against hepatitis B one month after vaccination (challenge vaccination) with a stand alone monovalent hepatitis B vaccine. Primary objectives: To describe the persistence of anti-hepatitis B antibody at 9 to 10 years of age after last priming dose in subjects having received hepatitis B vaccine at birth and a hexavalent vaccine at 2, 4 and 6 months of age according to the vaccine received during A3L12 study (Hexaxim® [Group 1] or Infanrix® hexa [Group 2]) To evaluate the immune response against hepatitis B one month after vaccination with a stand alone monovalent hepatitis B vaccine (challenge vaccination). Secondary objectives: To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.

Detailed Description
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Subjects age 9 to 10 years who had received 3 injections of Hexaxim® or Infanrix® hexa and have completed the A3L12 study will be invited to participate in this study. They will receive one dose of Euvax-B® vaccine at Day 0.

Official Title
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Persistence of Anti-Hep B Antibodies at 9 to 10 Years of Age in Subjects Having Received Hep B Vaccine at Birth and a DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine at 2, 4 and 6 Months of Age, and Evaluation of Their Immune Memory Following a Challenge Re-vaccination With a Stand Alone Hep B Vaccine

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Euvax B®: Hepatitis B vaccine
* Biological: Euvax B®: Hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed by subject's parent/legally acceptable representative Assent form signed by subject Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures Receipt of primary vaccination with 3 doses of either Hexaxim® or Infanrix® hexa at the age of 2, 4, and 6 months in the A3L12 study, and hepatitis B vaccine at birth. Exclusion Criteria: Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial Incomplete primary immunization in the A3L12 study Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral polio vaccine [OPV] in the context of oral polio vaccine-national immunization days [OPV-NIDs] does not fall within the scope of this exclusion criterion) Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease) Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 10 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hexaxim® Group<br>Subjects that received Hexaxim® in Study A3L12 | Biological: Euvax B®: Hepatitis B vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Euvax B®;|
| Experimental: Infanrix® hexa Group<br>Subjects that received Infanrix® hexa in Study A3L12 | Biological: Euvax B®: Hepatitis B vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Euvax B®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study |  | Day 0 (pre-vaccination) | 
| Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study following vaccination with Euvax B® vaccine |  | Day 28 (post-vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study |  | Day 0 up to Day 28 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine, Euvax-B®, Hexaxim®, Infanrix® hexa