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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00684671

Purpose

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.

Condition	Intervention	Phase
Hepatitis A Hepatitis B	Biological: Twinrix Biological: Engerix-B Biological: Havrix Biological: HBVAXPRO Biological: Vaqta	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Memory

Drug Information available for: Hepatitis B Vaccines Hepatitis A Vaccines Twinrix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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: Yes ]
Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: 4-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
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: Yes ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms. [ Time Frame: 31-day follow-up period after challenge dose. ] [ Designated as safety issue: Yes ]
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: Yes ]

Estimated Enrollment:	293
Study Start Date:	May 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group C: Active Comparator	Biological: HBVAXPRO Intramuscular injection, single dose in the left deltoid. Biological: Vaqta Intramuscular injection, single dose in right deltoid.
Group B: Active Comparator	Biological: Engerix-B Intramuscular injection, single dose in left deltoid. Biological: Havrix Intramuscular injection, single dose in right deltoid.
Group A: Experimental	Biological: Twinrix Intramuscular injection, single dose in left deltoid.

Eligibility

Ages Eligible for Study:	41 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684671

Locations

Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111572
Study First Received:	May 23, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00684671
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

Combined hepatitis A and B vaccine
Immune memory
> 41 years old

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B

Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
DNA Virus Infections
Enterovirus Infections

Additional relevant MeSH terms:

RNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009