Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||To Evaluate Immune Response to a Hepatitis B Vaccine (Engerix™-B ) Challenge Dose in Healthy Subjects Who Received GSK Biologicals' Hepatitis B Vaccine (Engerix™-B ) Approximately 20 Years Ago as Primary Vaccination at 0, 1, 2 and 12 Months.|
- Number of Participants With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Specific Cut-off Values [ Time Frame: One month after the hepatitis B vaccine challenge dose ]The cut-off values assessed include: ≥ 3.3 Milli International Units per Milliliter (mIU/mL), ≥ 10 mIU/mL, and ≥ 100 mIU/mL.
- Occurrence, Intensity and Relationship to Vaccination of Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period after the challenge dose of hepatitis B vaccine. ]
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An AE is considered severe if it prevents normal, everyday activities.
- Number of Participants Reporting Any Serious Adverse Events (SAEs). [ Time Frame: Up to 1 month after the challenge dose. ]
An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
|Study Start Date:||April 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Group Engerix™-B
Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
Intramuscular injection, 1 dose
Other Name: Hepatitis B vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456625
|GSK Investigational Site|
|Bangkok, Thailand, 10330|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|