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Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
This study has been completed.
Study NCT00684671   Information provided by GlaxoSmithKline
First Received: May 23, 2008   Last Updated: June 4, 2009   History of Changes

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 ]
  • 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 ]
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 ]
  • 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. ]
 
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
  • Hepatitis A
  • Hepatitis B
  • Biological: Twinrix
  • Biological: Engerix-B
  • Biological: Havrix
  • Biological: HBVAXPRO
  • Biological: Vaqta
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP