Study to Show That the Combined Hepatitis A and B Vaccine is Non-Inferior to Monovalent Vaccines in Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00603252

Purpose

This protocol posting describes the booster phase of the study. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731)

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

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:	Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Bios' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-Inferiority Between the Vaccines in Adults.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HAV immune response to the challenge dose
Anti-HBs antibody response to the challenge dose

Secondary Outcome Measures:

Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects [ Time Frame: Two weeks and one month after the challenge dose ]
Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects [ Time Frame: Two weeks and one month after the challenge dose ]
Occurrence and intensity of solicited local symptoms [ Time Frame: In the 4-day follow-up period after the challenge dose ]
Occurrence, intensity and relationship of solicited general symptoms [ Time Frame: In the 4-day follow-up period after the challenge dose ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported [ Time Frame: During the 31-day follow-up period after the challenge dose ]
Occurrence of all serious adverse events (SAEs) reported [ Time Frame: Following the administration of the challenge dose ]

Estimated Enrollment:	495
Study Start Date:	January 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

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 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 completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, 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: NCT00603252

Locations

Germany, Brandenburg
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
Germany, Sachsen
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
Germany, Schleswig-Holstein
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111149
Study First Received:	January 16, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00603252
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

combined hepatitis A and B vaccine
risk factors

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 14, 2009