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

Sponsor:	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: Engerix-B Biological: Havrix Biological: Twinrix Biological: HBVAXPRO Biological: Vaqta	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B Memory

Drug Information available for: Twinrix Hepatitis A Vaccines

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]
Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies [ Time Frame: One month after the challenge dose. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Prior to administration of challenge dose ] [ Designated as safety issue: No ]
Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations [ Time Frame: Two weeks and one month after the challenge dose ] [ Designated as safety issue: No ]
Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
Number of Subjects Reporting Unsolicited Symptoms [ Time Frame: During the 31-day follow-up period after the challenge dose. ] [ Designated as safety issue: No ]
Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination [ Time Frame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) ] [ Designated as safety issue: No ]
Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During one month following the administration of the challenge dose ] [ Designated as safety issue: No ]

Enrollment:	506
Study Start Date:	May 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HB VAX PRO + Vaqta Group: Active Comparator Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).	Biological: HBVAXPRO Intramuscular injection, single dose in the left deltoid. Biological: Vaqta Intramuscular injection, single dose in right deltoid.
Engerix + Havrix Group: Active Comparator Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).	Biological: Engerix-B Intramuscular injection, single dose in left deltoid. Biological: Havrix Intramuscular injection, single dose in right deltoid.
Twinrix Group: Experimental Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).	Biological: Twinrix Intramuscular injection, single dose in left deltoid.

Eligibility

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 (NCT 00603252).
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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111572
Study First Received:	May 23, 2008
Results First Received:	October 29, 2009
Last Updated:	February 12, 2010
ClinicalTrials.gov Identifier:	NCT00684671 History of Changes
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

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Hepatitis B

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

ClinicalTrials.gov processed this record on March 18, 2010