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Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

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ClinicalTrials.gov Identifier: NCT00289718
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : August 26, 2010
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.


Condition or disease Intervention/treatment Phase
Hepatitis B Hepatitis A Biological: Twinrix™ adult Phase 3

Detailed Description:

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited during the course of this long-term study.

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 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers
Study Start Date : November 1, 2004
Primary Completion Date : March 2, 2005
Study Completion Date : March 2, 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Twinrix Group

Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.

As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up.

Biological: Twinrix™ adult
Intramuscular administration



Primary Outcome Measures :
  1. Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]
    Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL).

  2. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination ]
    Solicited local symptoms assessed include pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.

  3. Number of Subjects Seropositive for Anti-HAV Antibodies [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]
    A seropositive subject was defined as a vaccinated subject who had a anti-HAV antibody titres ≥ 33 mIU/ml.

  4. Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]
    Concentrations given as GMC expressed as mIU/mL. NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA). From Year 11 to Year 14, anti-HBs antibody concentrations were tested with ELISA with cut-off of 3.3 mIU/mL while, Year 14* onwards, anti-HBs antibody concentrations were tested with the CLIA with cut-off of 6.2 mIU/mL.

  5. Number of Subjects Seropositive for Anti-HB Antibodies [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]

    A seropositive subject was defined as a vaccinated subject who had anti-HB antibody titres ≥ 1 mIU/mL.

    NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)


  6. Number of Subjects Seroprotected for Anti-HBs Antibodies. [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]

    A seroprotected subject was defined as a subjects with the anti-HBs titres ≥ 10 mIU/mL.

    NOTE: There was a change of assay kit at Year 15 time-point, thus for the sake of bridging, blood samples corresponding to Year 14 were re-tested with ChemiLuminescence ImmunoAssay (CLIA)


  7. Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the follow-up period after additional vaccination (minimum 30 days) ]
    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

  8. Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: Before the additional dose and 1 month after the additional dose ]
    Concentrations given as GMC expressed as mIU/mL. If a subject became seronegative (< 10 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

  9. Number of Subjects Reporting Any Solicited General Symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination ]
    Solicited general symptoms assessed included fatigue, headache, malaise, nausea, vomiting and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination.

  10. Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 30-day follow-up period after additional vaccination ]
    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.

  11. Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination ]
    A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
  • Written informed consent will be obtained from each subject before the blood sampling visit of each year

Information from the National Library of Medicine

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): NCT00289718


Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 100556 (Y11)
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 100556 (Y11)
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 100556 (Y11)
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100556 (Y11)
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100556 are summarised with studies 100557, 100558, 100559, and 100560 on the GSK Clinical Study Register.
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 100556 (Y11)
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289718     History of Changes
Other Study ID Numbers: 100556 (Y11)
100557 (Y12) ( Other Identifier: GSK )
100558 (Y13) ( Other Identifier: GSK )
100559 (Y14) ( Other Identifier: GSK )
100560 (Y15) ( Other Identifier: GSK )
First Posted: February 10, 2006    Key Record Dates
Results First Posted: August 26, 2010
Last Update Posted: February 15, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
Combined Hepatitis A and B vaccine
Hepatitis A
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs