| May 23, 2008 |
| June 4, 2009 |
| May 2008 |
| November 2008 (final data collection date for primary outcome measure) |
- Anti-HAV antibody response to the challenge dose [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]
- Anti-HBs antibody response to the challenge dose [ Time Frame: One month after the challenge dose ] [ Designated as safety issue: No ]
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- Anti-HAV antibody response to the challenge dose [ Time Frame: One month after the challenge dose. ]
- Anti-HBs antibody response to the challenge dose [ Time Frame: One month after the challenge dose ]
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| Complete list of historical versions of study NCT00684671 on ClinicalTrials.gov Archive Site |
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: 31-day follow-up period after challenge dose. ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of all SAEs following the administration of the challenge dose. [ Time Frame: Following the administration of the challenge dose. ] [ Designated as safety issue: No ]
- Anti-HAV and anti-HBs antibody concentrations at Month 48 [ Time Frame: At Month 48 after primary vaccination ] [ Designated as safety issue: No ]
- Anti-HAV antibody concentrations after the challenge dose [ Time Frame: Two weeks and one month after the challenge dose. ] [ Designated as safety issue: No ]
- Anti-HBs antibody concentrations after the challenge dose. [ Time Frame: Two weeks and one month after the challenge dose. ] [ Designated as safety issue: No ]
- Occurrence and intensity of solicited local symptoms. [ Time Frame: 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
- Retrospective recording of all serious adverse events (SAEs) with causal relationship to vaccination or referring to hepatitis A or B infection that occurred since the last study visit of the HAB-160 long-term follow-up study. [ Time Frame: since the last study visit of the HAB-160 long-term follow-up study. ] [ Designated as safety issue: No ]
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- Anti-HAV and anti-HBs antibody concentrations at Month 48 [ Time Frame: At Month 48 after primary vaccination ]
- Anti-HAV antibody concentrations after the challenge dose [ Time Frame: Two weeks and one month after the challenge dose. ]
- Anti-HBs antibody concentrations after the challenge dose. [ Time Frame: Two weeks and one month after the challenge dose. ]
- Occurrence and intensity of solicited local symptoms. [ Time Frame: 4-day follow-up period after vaccination ]
- Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 4-day follow-up period after vaccination ]
- Retrospective recording of all serious adverse events (SAEs) with causal relationship to vaccination or referring to hepatitis A or B infection that occurred since the last study visit of the HAB-160 long-term follow-up study. [ Time Frame: since the last study visit of the HAB-160 long-term follow-up study. ]
- Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: 31-day follow-up period after challenge dose. ]
- Occurrence, intensity and relationship to vaccination of all SAEs following the administration of the challenge dose. [ Time Frame: Following the administration of the challenge dose. ]
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| |
| Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination |
| Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination. |
Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study. |
| |
| Phase IV |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
|
|
- Biological: Twinrix
- Biological: Engerix-B
- Biological: Havrix
- Biological: HBVAXPRO
- Biological: Vaqta
|
| |
| |
| |
| Completed |
| 293 |
| November 2008 |
| November 2008 (final data collection date for primary outcome measure) |
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 HAB-160 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 the vaccination.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, 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.
|
| Both |
| 41 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Czech Republic |
| |
| NCT00684671 |
| Study Director, GSK |
| 111572 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| May 2009 |