Clinical trial NCT00289731: Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Official title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Hepatitis A
Keywords: Combined hepatitis A and hepatitis B vaccine
Hepatitis B
Hepatitis A
Monovalent hepatitis A and hepatitis B vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 596
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description: The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.

Eligibility criteria: Inclusion criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
* Written informed consent obtained from the subject.
* No serological signs of hepatitis A or B infection at screening.
* 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 (drug or vaccine) 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 100382.
* 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.
* Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

Primary outcomes:
measure: Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
timeFrame: At Month 7 after Twinrix vaccination
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
timeFrame: At Month 7
Secondary outcomes:
measure: Anti-HAV and Anti-HBs Antibody Concentrations
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Alcohol Consumption
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Concomitant Medication
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Medical Condition
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Gender
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Age
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by BMI
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Smoking Status
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Alcohol Consumption
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Concomitant Medication
timeFrame: At Month 7
measure: Number of Seroprotected Subjects Against HBs Antigen, by Medical Condition
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Gender
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Age
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by BMI
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Smoking Status
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Alcohol Consumption
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Concomitant Medication
timeFrame: At Month 7
measure: Anti-HAV and Anti-HBs Antibody Concentrations, by Medical Condition
timeFrame: At Month 7
measure: Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
timeFrame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
measure: Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
timeFrame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
measure: Anti-HAV and Anti-HBs Antibody Concentrations
timeFrame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to Month 7
measure: Number of Subjects With SAEs
timeFrame: At Month 12 (M12), Month 24 (M24) and Month 36 (M36)
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Hradec Kralove
country: Czechia
facility: GSK Investigational Site
city: Finsterwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geringswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Elmshorn
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van der Wielen M, Van Damme P, Chlibek R, Smetana J, von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine. 2006 Jun 29;24(26):5509-15. doi: 10.1016/j.vaccine.2006.04.016. Epub 2006 May 4.