Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Study Overview
=================
Brief Summary
-----------------
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).

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.

Official Title
-----------------
Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults

Conditions
-----------------
Hepatitis B, Hepatitis A

Intervention / Treatment
-----------------
* Biological: Twinrix
* Biological: Engerix-B
* Biological: Havrix
* Biological: HBVAXPRO
* Biological: Vaqta


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 41 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Twinrix|nan|
|Biological: Engerix-B|nan|
|Biological: Havrix|nan|
|Biological: HBVAXPRO|nan|
|Biological: Vaqta|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HAV immune response to the challenge dose |  |  | 
| Anti-HBs antibody response to the challenge dose |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
combined hepatitis A and B vaccine, risk factors