Long-term Persistence Study in Healthy Adults Previously Vaccinated With Twinrix Adult

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01037114
Collaborator
(none)
50
1
1
49.1
1

Study Details

Study Description

Brief Summary

This study will evaluate the persistence of the immune response to HAV (hepatitis A virus) antigens and HBs (hepatitis B surface) antigens in healthy adults previously vaccinated with Twinrix Adult in the primary study, HAB-032 (208127/022). The subjects will be invited for blood sampling 16, 17, 18, 19 and 20 years after the primary vaccination to evaluate the antibody persistence. For subjects in whom low circulating antibodies are detected, the presence of immune memory against hepatitis A & B antigens will be investigated by the administration of a challenge dose of the appropriate vaccine (Havrix and/or Engerix-B) at the next planned visit.

No new subjects will be recruited during this study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood sampling
  • Biological: Engerix-B
  • Biological: Havrix
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
An Open Single Centre Study to Evaluate the Long-term Antibody Persistence and Immune Memory Between 16 and 20 Years After the Primary Study HAB-032 (208127/022) in Which Healthy Adults Were Vaccinated With Twinrix Adult Following a Three-dose Schedule.
Actual Study Start Date :
Jan 27, 2010
Actual Primary Completion Date :
Feb 28, 2014
Actual Study Completion Date :
Feb 28, 2014

Arms and Interventions

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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.

Procedure: Blood sampling
Blood sampling at Year 16, 17, 18, 19 and 20 and at the time of challenge dose administration and 14 days and one month after challenge dose administration (if challenge dose needed).

Biological: Engerix-B
Engerix-B will be administered to subjects who are not seroprotected against hepatitis B.

Biological: Havrix
Havrix will be administered to subjects who are seronegative for anti-HAV antibodies.

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL) [At Years 16, 17, 18, 19 and 20.]

    Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.

  2. Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs) [At Years 16, 17, 18, 19 and 20.]

    Concentrations were expressed as GMCs in mIU/mL.

Secondary Outcome Measures

  1. Anti-HBs Concentrations After the Challenge Dose of Engerix-B [Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.]

    Concentration was given in mIU/mL. Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion.

  2. Anti-HAV Concentrations After the Challenge Dose of Havrix [Before, 14 days and one month (30 days) after the challenge dose of Havrix.]

    Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.

  3. Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B [30 days after the challenge dose of Engerix-B.]

    At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B. Anti-HBs anamnestic response to the challenge dose was defined as: Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point. At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point.

  4. Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix [30 days after the challenge dose of Havrix.]

    Anti-HAV anamnestic response to the challenge dose was defined as: Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point. At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point. Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point.

  5. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.]

    At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. 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.

  6. Number of Subjects With Serious Adverse Events (SAEs) [During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.]

    Only 1 subject received a challenge dose at Year 16 of Engerix-B. 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.

  7. Number of Subjects With Serious Adverse Events (SAEs) [During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.]

    One subject received a challenge dose of Havrix at Year 18 and another at Year 20. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  8. Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication [Up to Year 20.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

  • A male or female who received the complete primary vaccination course in the primary study 208127/022.

  • Written informed consent obtained from the subject.

All subjects must satisfy the following criteria at entry into the challenge dose phase:
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

  • A male or female who received the complete primary vaccination course in the primary study 208127/022.

  • Written informed consent obtained from the subject.

  • Subjects who participated in the LTFU phase of the 208127/022 study and for whom the antibody concentrations were below the cut-off at the last available follow-up time-point.

  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and

  • has a negative pregnancy test on the day of vaccination, and

  • has agreed to continue adequate contraception for two months after the administration of the challenge dose.

Exclusion Criteria:

The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:

  • Use of any investigational or non-registered product within 30 days prior to blood sampling.

  • Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study 208127/022.

  • History of hepatitis A or hepatitis B infection since the primary study 208127/022.

  • Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.

The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:

  • Use of any investigational or non-registered product within 30 days prior to study start or planned use during the study.

  • Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit.

  • History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit.

  • History of anaphylactic reactions following the administration of vaccines.

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

  • Acute disease and/or fever at the time of enrolment.

  • Pregnant or lactating female.

  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Gent Belgium 9000

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037114
Other Study ID Numbers:
  • 112266
First Posted:
Dec 21, 2009
Last Update Posted:
Feb 1, 2019
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 1 subject who was not able to come at Year (Y) 16 entered the study at Y17. At Y16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix vaccine. None of the subjects received a challenge dose at Y17 and Y19.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Period Title: Year 16
STARTED 49
COMPLETED 49
NOT COMPLETED 0
Period Title: Year 16
STARTED 48
COMPLETED 48
NOT COMPLETED 0
Period Title: Year 16
STARTED 44
COMPLETED 44
NOT COMPLETED 0
Period Title: Year 16
STARTED 45
COMPLETED 45
NOT COMPLETED 0
Period Title: Year 16
STARTED 45
COMPLETED 44
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Overall Participants 49
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
37.4
(5.66)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
38.6
(5.73)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
39.7
(5.89)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
40.7
(5.88)
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
41.7
(5.9)
Sex: Female, Male (Count of Participants)
Female
40
81.6%
Male
9
18.4%
Sex: Female, Male (Count of Participants)
Female
38
77.6%
Male
10
20.4%
Sex: Female, Male (Count of Participants)
Female
35
71.4%
Male
9
18.4%
Sex: Female, Male (Count of Participants)
Female
36
73.5%
Male
9
18.4%
Sex: Female, Male (Count of Participants)
Female
36
73.5%
Male
9
18.4%

Outcome Measures

1. Primary Outcome
Title Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)
Description Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.
Time Frame At Years 16, 17, 18, 19 and 20.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 28
anti-HAV >= 15 mIU/mL [at Year 16] (N=28)
28
anti-HBs >= 6.2 mIU/mL [at Year 16] (N=28)
27
anti-HBs >= 10 mIU/mL [at Year 16] (N=28)
27
anti-HAV >= 15 mIU/mL [at Year 17] (N=27)
26
anti-HBs >= 6.2 mIU/mL [at Year 17] (N=27)
25
anti-HBs >= 10 mIU/mL [at Year 17] (N=27)
25
anti-HAV >= 15 mIU/mL [at Year 18] (N=25)
25
anti-HBs >= 6.2 mIU/mL [at Year 18] (N=25)
23
anti-HBs >= 10 mIU/mL [at Year 18] (N=25)
23
anti-HAV >= 15 mIU/mL [at Year 19] (N=25)
24
anti-HBs >= 6.2 mIU/mL [at Year 19] (N=25)
23
anti-HBs >= 10 mIU/mL [at Year 19] (N=25)
23
anti-HAV >= 15 mIU/mL [at Year 20] (N=25)
24
anti-HBs >= 6.2 mIU/mL [at Year 20] (N=25)
23
anti-HBs >= 10 mIU/mL [at Year 20] (N=25)
23
2. Primary Outcome
Title Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)
Description Concentrations were expressed as GMCs in mIU/mL.
Time Frame At Years 16, 17, 18, 19 and 20.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 28
anti-HAV [at Year 16] (N=28)
262.5
anti-HBs [at Year 16] (N=28)
79.9
anti-HAV [at Year 17] (N=27)
369.4
anti-HBs [at Year 17] (N=27)
71.7
anti-HAV [at Year 18] (N=25)
237.7
anti-HBs [at Year 18] (N=25)
61.3
anti-HAV [at Year 19] (N=25)
234.3
anti-HBs [at Year 19] (N=25)
59.7
anti-HAV [at Year 20] (N=25)
229.3
anti-HBs [at Year 20] (N=25)
57.7
3. Secondary Outcome
Title Anti-HBs Concentrations After the Challenge Dose of Engerix-B
Description Concentration was given in mIU/mL. Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion.
Time Frame Before, 14 days and one month (30 days) after the challenge dose of Engerix-B.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 1
before challenge dose at Year 16
7.86
14 days after challenge dose at Year 16
50640.0
1 month (Day 30) after challenge dose at Year 16
31442.0
4. Secondary Outcome
Title Anti-HAV Concentrations After the Challenge Dose of Havrix
Description Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.
Time Frame Before, 14 days and one month (30 days) after the challenge dose of Havrix.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 2
before challenge dose at Year 18
25
14 days after challenge dose at Year 18
3421
1 month (Day 30) after challenge dose at Year 18
3389
before challenge dose at Year 20
19
14 days after challenge dose at Year 20
1096
1 month (Day 30) after challenge dose at Year 20
1060
5. Secondary Outcome
Title Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B
Description At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B. Anti-HBs anamnestic response to the challenge dose was defined as: Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point. At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point.
Time Frame 30 days after the challenge dose of Engerix-B.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 1
Number [Subjects]
1
6. Secondary Outcome
Title Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix
Description Anti-HAV anamnestic response to the challenge dose was defined as: Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point. At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point. Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point.
Time Frame 30 days after the challenge dose of Havrix.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 2
Number [subjects]
2
7. Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description At Year 16, 1 subject was administered a challenge dose of Engerix-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix. 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.
Time Frame 31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 3
Number [Subjects]
1
8. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Description Only 1 subject received a challenge dose at Year 16 of Engerix-B. 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.
Time Frame During the 31-day (Days 0-30) follow-up period after the Engerix-B challenge dose.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 1
Number [Subjects]
0
9. Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Description One subject received a challenge dose of Havrix at Year 18 and another at Year 20. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the 31-day (Days 0-30) follow-up period after the Havrix challenge dose.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 2
Number [subjects]
0
10. Secondary Outcome
Title Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication
Description 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.
Time Frame Up to Year 20.

Outcome Measure Data

Analysis Population Description
The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
Measure Participants 49
Number [Subjects]
0

Adverse Events

Time Frame SAEs: During the 31-day (Days 0 to 30) follow-up period after the challenge dose and from the beginning of the long term follow-up to Year 20; Unsolicited symptoms: During the 31-day (Days 0 to 30) follow-up period after the challenge dose.
Adverse Event Reporting Description As no challenge dose was administered during Years 17 and 19 time points, SAEs and other adverse events were not assessed. At Year 16, 1 subject was administered a challenge dose of Engerix-B vaccine and at Years 18 and 20, 2 subjects were administered a challenge dose of Havrix vaccine, for whom the SAEs and other adverse events were assessed during the 31 day period post challenge dose. SAEs were also collected for the entire safety follow-up.
Arm/Group Title Twinrix Group
Arm/Group Description Subjects who received 3 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 first long-term follow-up NCT00289718 and this long-term follow-up. A challenge dose of the Havrix or Engerix-B vaccines can be administered in this study based on serology results at each time point.
All Cause Mortality
Twinrix Group
Affected / at Risk (%) # Events
Total 0/49 (0%)
Serious Adverse Events
Twinrix Group
Affected / at Risk (%) # Events
Total 0/49 (0%)
Other (Not Including Serious) Adverse Events
Twinrix Group
Affected / at Risk (%) # Events
Total 1/3 (33.3%)
Musculoskeletal and connective tissue disorders
Back pain 1/3 (33.3%) 1

Limitations/Caveats

A decrease in specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody(10-100 mIU/mL).The tables show updated results following complete retesting/reanalysis for Y16-18.Y19 & 20 results were only analyzed by CLIA.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01037114
Other Study ID Numbers:
  • 112266
First Posted:
Dec 21, 2009
Last Update Posted:
Feb 1, 2019
Last Verified:
Jan 1, 2018