Hepatitis B, Hepatitis A
Conditions
Keywords
combined hepatitis A and B vaccine, risk factors
Brief summary
This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
Detailed description
All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female who completed the primary vaccination phase of the study. * Written informed consent obtained from 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 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute disease at the time of enrolment. * Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HAV immune response to the challenge dose | — |
| Anti-HBs antibody response to the challenge dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence and intensity of solicited local symptoms | In the 4-day follow-up period after the challenge dose |
| Occurrence, intensity and relationship of solicited general symptoms | In the 4-day follow-up period after the challenge dose |
| Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects | Two weeks and one month after the challenge dose |
| Occurrence of all serious adverse events (SAEs) reported | Following the administration of the challenge dose |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported | During the 31-day follow-up period after the challenge dose |
| Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects | Two weeks and one month after the challenge dose |
Countries
Belgium, Germany
Outcome results
None listed