challenge dose of Engerix B to assess the quality of the persisting immune memory against hepatitis B in children aged 6 to 7 years MedDRA version: 20.0 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Engerix B
Product Name: Engerix B
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Hepatitis B virus
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 6 to 7 years on the day of vaccination ("6 to 7 years" means from the day of the 6th birthday to the day before the 8th birthday). -Informed Consent Form (ICF) has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed by the subject able to read. -Receipt of 3 doses of either Hexyon or Infanrix hexa vaccine at the age of 3, 5, and 11 to 12 months in Study A3L38 with a post-dose 3 anti-hepatitis B (HB)s antibody titer available. Are the trial subjects under 18? yes Number of subjects for this age range: 487 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. -Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination except for influenza vaccination, which may be received less than 4 weeks before study vaccine. -Subject known to have received HB containing vaccine after completion of Study A3L38 procedures. -Receipt of immune globulins, blood or blood-derived products in the past 3 months. -Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). -History or diagnosis of an of HB infection, confirmed either clinically, serologically, or microbiologically after completion of Study A3L38 procedures. -Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances. -Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion. -Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. -Some criteria are temporarily exclusion criteria. In case a subject meets any of these criteria, a further appointment will be scheduled to reassess the subject’s eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •-To describe the persistence of anti-hepatitis B surface (HBs) antibodies at 6 to 7 years of age in subjects having received an hexavalent vaccine at 3, 5 and 11 to 12 months of age according to the vaccine received during Study A3L38 (Hexyon [Group 1] or Infanrix hexa [Group 2]) -To evaluate the immune response against HBs antigen one month after a vaccination with a standalone monovalent HB vaccine (challenge dose) ;Secondary Objective: -To describe serious adverse events (SAEs) reported throughout the study ; Primary end point(s): Individual anti-hepatitis B surface (HBs) antibody concentrations Individual anti-HBs antibody concentration ratios (one month post-/pre-vaccination) Individual anti-HBs antibody concentrations = 10 mIU/mL and = 100 mIU/mL Anamnestic response rate ;Timepoint(s) of evaluation of this end point: Baseline and/or Day 28 (post-vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of Serious Adverse Events (SAEs);Timepoint(s) of evaluation of this end point: Baseline to Day 28 (post-vaccination) | — |
Countries
Finland
Contacts
Public ContactGlobal Medical Affairs
Sanofi Pasteur
Outcome results
None listed