To protect healthy volunteers between the ages of 12 and 15 years against hepatitis A and hepatitis B viruses and to determine the optimal dose range and schedule of the combined hepatitis A / hepatitis B vaccine, with respect to immunogenicity, reactogenicity and safety in this age group.
Conditions
Interventions
Trade Name: Twinrix Adult
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: HAV
Other descriptive name: HEPATITIS A VIRUS (INACTIVATED)
Concentration unit: ELI
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For primary study: Healthy male and female volunteers between the ages of 12-15 years at first vaccination will be enrolled in this study. Negative titres for anti-HAV, anti-HBs, anti-HBc antibodies and / or HBsAg. Age: between 12 and 15 years at the time of the first vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent obtained from the parent / guardian of the subject. If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions. For the LTFU: Subjects who had received at least one dose of the study vaccine in the primary study HAB-084. Written informed consent was obtained from each subject or parent/guardian of the subject before the first blood-sampling visit of the follow-up. Are the trial subjects under 18? yes Number of subjects for this age range: 300 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: Use of any investigational or non-registered drug or vac-cine other than the study vaccines during the study period or within 30 days preceding the first dose of study vaccine. Administration of chronic immunosuppressants or other immune-modifying drugs within six months. Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after. Previous vaccination against hepatitis A or hepatitis B. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. Family history of congenital or hereditary immunodeficiency History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at the time of enrollment. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Oral or axillary temperature of >= 37.5° C. Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For primary study: To demonstrate, that the immunogenicity elicited by the combined hepatitis A / hepatitis B vaccine Twin-rix is at least equivalent to that of Twinrix Junior vaccine, by measuring the anti-HAV and anti-HBs antibody levels reached at month 7. For the long term follow-up (LTFU): To evaluate anti-HAV and anti-HBs antibody per-sistence at Year 6 (i.e. Month 72), Year 7 (i.e. Month 84), Year 8 (i.e. Month 96), Year 9 (i.e. Month108) and Year 10 (i.e. Month 120) after the first vaccine dose of the two-dose or three-dose primary vaccination. ;Secondary Objective: To compare the immunogenicity elicited by the combined hepatitis A / hepatitis B vaccine Twinrix to that of the Twinrix Junior vaccine by measuring the anti-HAV and anti-HBs antibody levels reached at months 1, 2, and 6. To compare the safety and reactogenicity of the combined hepatitis A / hepatitis B vaccine Twinrix? to that of Twinrix? Junior vaccine after each vaccine dose. ;Primary end point(s): Titres for anti-Hepatitis A virus (HAV) antibodies and for anti-Hepatitis B surface antigen (HBs) antibodies. For the LTFU: Anti-HAV seropositivity rates and GMCs (calculated on ser positive subjects). Anti-HBs seropositivity rates, proportion of subjects with antibody concentrations >=10 mIU/mL and GMCs (calculated on seropositive subjects).;Timepoint(s) of evaluation of this end point: For primary study endpoint: At Month 7 For LTFU endpoints: At all the LTFU points (At Years 6, 7, 8, 9 and 10). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Titres for anti-HAV and anti-HBs antibodies. Reactogenicity after each dose (defined as solicited adverse events [AEs], unsolicited adverse events and serious adverse events [SAEs} reported). For the LTFU: SAEs that are determined by the investigator to have a causal relationship to primary vaccination, any event related to a lack of vaccine efficacy (i. e. hepatitis A or hepatitis B infection), SAEs that are related to study participation (blood sampling). ;Timepoint(s) of evaluation of this end point: For anti-HAV and anti-HBs antibodies titres: At month 1, 2, and 6. For solicited AEs-reported on the day of vaccination (Day 0) and during the three-day follow-up period after each vaccine dose (Day 0 to Day 3). For unsolicited AEs-Occurring within 30 days after each vaccine dose (Day 0 to Day 30). For SAEs-During the course of the study (Month 0 to Month7). For SAEs in LTFU: At all the LTFU time-points (At Years 6, 7, 8, 9 and 10). | — |
Countries
Belgium, Czech Republic
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed