Clinical trial NCT02697474: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine
Euvax-B®
Hexaxim®
Infanrix® hexa
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

* 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
timeFrame: Day 0 (pre-vaccination)
measure: 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
timeFrame: Day 28 (post-vaccination)
Secondary outcomes:
measure: Number of subjects reporting Serious Adverse Events and relatedness to study vaccine throughout the study
timeFrame: Day 0 up to Day 28 post-vaccination
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References: