Hepatitis B Clinical Trial
Official title:
Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
Verified date | July 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the long-term persistence of hepatitis A and B
antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary
vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives & outcome measures of the extension phase at year
6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Status | Completed |
Enrollment | 178 |
Est. completion date | April 15, 2009 |
Est. primary completion date | April 15, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine. - Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year. |
Country | Name | City | State |
---|---|---|---|
Belgium | GSK Investigational Site | Wilrijk |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration | Years 6, 7, 8, 9, and 10. | ||
Primary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | At Year 6, 7, 8, 9 and 10 | ||
Primary | Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration | Before and 1 month after the additional dose administration | ||
Primary | Number of Subjects With Immune Response to the Additional Dose of Engerix™-B | Immune response was defined as: anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points. |
One month after the additional dose administration | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | At Year 6, 7, 8, 9 and 10 | |
Primary | Number of Subjects Reporting Solicited Local and General Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. | During the 4-day follow-up period after additional dose | |
Primary | Number of Subjects Reporting Unsolicited Adverse Events | Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | During the 30-day follow-up period after additional dose | |
Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | During the 30-day follow-up period after additional dose |
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