Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

Condition(s) targeted: Hepatitis A; Hepatitis B

Intervention: Twinrix (Biological); Engerix-B (Biological); Havrix (Biological); HBVAXPRO (Biological); Vaqta (Biological)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Anti-HAV antibody response to the challenge dose

Anti-HBs antibody response to the challenge dose

Secondary outcome:

Anti-HAV and anti-HBs antibody concentrations at Month 48

Anti-HAV antibody concentrations after the challenge dose

Anti-HBs antibody concentrations after the challenge dose.

Occurrence and intensity of solicited local symptoms.

Occurrence, intensity and relationship of solicited general symptoms

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.

Occurrence, intensity and relationship to vaccination of unsolicited symptoms.

Occurrence, intensity and relationship to vaccination of all SAEs following the administration of the challenge dose.

Minimum age: 41 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Wilrijk, Belgium; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

GSK Clinical Trials Call Center, Kralove, Czech Republic; Not yet recruiting
GSK Clinical Trials Call Center, Phone: 1-877-379-3718

Starting date: May 2008
Last updated: May 28, 2008