Immune Response to Hepatitis B Vaccine Challenge Dose in Subjects Who Received a Primary Neonatal Hepatitis B Vaccine.
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|ClinicalTrials.gov Identifier: NCT00456625|
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : May 15, 2009
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B||Biological: Engerix™-B||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456625
|GSK Investigational Site|
|Bangkok, Thailand, 10330|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|