Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289744
• Other study ID #: 100561 (Y6)
• Secondary ID: 100562 (Year 7)1
• Status: Completed
• Phase: Phase 3
• Start date: February 16, 2004
• Est. completion date: April 15, 2009

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• TWINRIX™ ADULT
2 doses IM injection in primary study
• Engerix TM
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

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