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.
This trial is active, not recruiting.
|Treatments||euvax b®: hepatitis b vaccine|
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Start date||February 2016|
|End date||June 2016|
|Trial size||150 participants|
|Trial identifier||NCT02697474, A3L49, U1111-1161-2421|
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.
- 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).
- To describe serious adverse events (SAEs) reported throughout the trial after administration of hepatitis B vaccine.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
time frame: 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
time frame: Day 28 (post-vaccination)
Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
time frame: Day 0 up to Day 28 post-vaccination
Male or female participants from 9 years up to 10 years old.
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.
|Official title||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|
|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.|
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