Antibody Response After Vaccination
Conditions
Keywords
combined hepatitis A and B vaccine, hepatitis B virus, immunity
Brief summary
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months. 1. To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13. 2. To compare the distribution of anti-HBs at these different moments.
Interventions
BIOLOGICALCombined vaccine against hepatitis A and B (Twinrix)
Sponsors
GlaxoSmithKline
IDEWE Occupational Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older; * a good physical condition as confirmed by history and physical examination at entry of the study; * for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen; * all participants have provided written informed consent.
Exclusion criteria
* Employees occupationally exposed to hepatitis B virus * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HBs antibodies concentration 1 month after 3th vaccine dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months) | — |
Countries
Belgium
Outcome results
None listed