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 Details
Study Description
Brief Summary
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:
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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])
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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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Hexaxim® Group Subjects that received Hexaxim® in Study A3L12 |
Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Names:
|
Experimental: Infanrix® hexa Group Subjects that received Infanrix® hexa in Study A3L12 |
Biological: Euvax B®: Hepatitis B vaccine
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study [Day 0 up to Day 28 post-vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent form signed by subject's parent/legally acceptable representative
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Assent form signed by subject
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Subject and parent(s)/legally acceptable representatives able to attend the scheduled visits and to comply with all trial procedures
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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:
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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
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Incomplete primary immunization in the A3L12 study
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Diagnostic of hepatitis B infection (clinical, serological, or virological confirmation) after completion of A3L12 study procedures
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Subjects known to have received hepatitis B vaccine after completion of the A3L12 study procedures
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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)
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Receipt of any blood, blood-derived products or immunosuppressant drugs at the latest 3 months before inclusion
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Known or suspected diagnostic of congenital or acquired immunodeficiency since completion of the A3L12 study procedures
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Serious chronic illness occurring after receipt of the primary series (e.g., leukemia, lymphoma [T or B cells], Crohn's disease)
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Known or suspected subject seropositivity against human immunodeficiency virus (HIV) or hepatitis C since completion of the A3L12 study procedures
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Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Bangkok | Thailand | |||
2 | Khon Kaen | Thailand |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur SA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A3L49
- U1111-1161-2421