Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

Phase 3

Completed

• Conditions: Hepatitis B; Hepatitis A
• Interventions: Biological: Twinrix™ Adult; Biological: Twinrix™ Junior

• Registration Number: NCT00197184
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Study Timeline

• Study Start: 2003-11-01
• Primary Completion: 2004-03-10
• Study Completion: 2004-03-10
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-20
• Results First Submitted: 2009-02-20
• Results First Submitted QC: 2009-04-10
• Results First Posted: 2009-06-04
• Status Verified: 2016-10
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Participation in primary study
• Written informed consent obtained before each long term follow up visit.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twinrix Adult	Twinrix™ Adult	Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
Twinrix Junior	Twinrix™ Junior	Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).

Primary Outcome Measures

Name	Time	Method
Anti-hepatitis B (HBs) Antibody Concentrations	Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)	Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.	Before and one month after additional vaccination	Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres \< 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.
Anti-hepatitis A (HAV) Antibody Concentrations	Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)	Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.	Before and One month after additional vaccination	Subjects losing seroprotective anti-HBs antibody titres (i.e. titres \< 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms	during the 4-day follow-up period after additional vaccination	Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.; Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.	During the 4-day follow-up period after additional vaccination	Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.; Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events	At least one month after additional vaccination	A serious adverse event (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.
Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.	From last study visit of the primary study up to Year 5 long term follow-up	A serious adverse event (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.
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).	During the 30-day follow-up period after additional vaccination.	An Adverse Event 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Valencia, Spain