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Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00875485
First received: April 2, 2009
Last updated: August 2, 2012
Last verified: July 2012
History of Changes
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Hepatitis B
Hepatitis A
Interventions: Procedure: Blood sampling
Biological: Additional challenge dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The amount of subjects who entered the study at the Year 13 time point differ from the Year 11 and Year 12 time point, because some of them came back at Year 13 but not at Year 11 and Year 12 or vice versa.

Reporting Groups
  Description
Twinrix Adult Group Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
Twinrix Junior Group Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study

Participant Flow for 3 periods

 Period 1:   Year 11
    Twinrix Adult Group     Twinrix Junior Group  
STARTED     99     111  
COMPLETED     99     111  
NOT COMPLETED     0     0  

Period 2:   Year 12
    Twinrix Adult Group     Twinrix Junior Group  
STARTED     101     109  
COMPLETED     101     109  
NOT COMPLETED     0     0  

Period 3:   Year 13
    Twinrix Adult Group     Twinrix Junior Group  
STARTED     102     113  
COMPLETED     102     113  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Twinrix Adult Group Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
Twinrix Junior Group Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
Total Total of all reporting groups

Baseline Measures
    Twinrix Adult Group     Twinrix Junior Group     Total  
Number of Participants  
[units: participants]
 		  99     111     210  
Age  
[units: years]
Mean ± Standard Deviation 		  24.5  ± 1.06     24.5  ± 1.05     24.5  ± 1.05  
Gender  
[units: participants]
 		     
Female     49     52     101  
Male     50     59     109  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.   [ Time Frame: At Year 11, 12 and 13 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. ]
  Show Outcome Measure 1

2.  Primary:   Anti-HAV Antibody Concentrations   [ Time Frame: At Year 11, 12 and 13 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. ]
  Show Outcome Measure 2

3.  Primary:   Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values   [ Time Frame: At Year 11, 12 and 13 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084 ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values
Measure Description

Anti-HBs antibody cut-off values assessed were >= 3.3 mIU/mL and >= 10 mIU/mL.

Data were analyzed up to Year 13. Results for additional time points will be disclosed when available.
Time Frame At Year 11, 12 and 13 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points

Reporting Groups
  Description
Twinrix Adult Group Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
Twinrix Junior Group Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study

Measured Values
    Twinrix Adult Group     Twinrix Junior Group  
Number of Participants Analyzed  
[units: participants]
 		  72     91  
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values  
[units: subjects]
 		   
Year 11 [3.3 mIU/mL] (N = 72;91)     70     89  
Year 12 [3.3 mIU/mL] (N = 66;86)     57     79  
Year 13 [3.3 mIU/mL] (N = 68;88)     59     83  
Year 11 [10 mIU/mL] (N= 72;91)     64     81  
Year 12 [10 mIU/mL] (N= 66;86)     54     75  
Year 13 [10 mIU/mL] (N= 68;88)     56     78  

No statistical analysis provided for Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values



4.  Primary:   Anti-HBs Antibody Concentrations   [ Time Frame: At Year 11, 12 and 13 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084. ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) or Hepatitis A or B Infection.   [ Time Frame: Since the last long-term follow-up visit up to Year 11. ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) or Hepatitis A or B Infection.   [ Time Frame: Since the last long-term follow-up visit up to Year 12. ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) or Hepatitis A or B Infection.   [ Time Frame: Since the last long-term follow-up visit up to Year 13. ]
  Show Outcome Measure 7

8.  Primary:   Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.   [ Time Frame: At Year 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084 ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

9.  Primary:   Anti-HAV Antibody Concentrations   [ Time Frame: At Year 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084 ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

10.  Primary:   Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values   [ Time Frame: At Year 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084 ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

11.  Primary:   Anti-HAV Anamnestic Response.   [ Time Frame: One month after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

12.  Primary:   Anti-HBs Antibody Concentrations   [ Time Frame: At Year 14 and 15 after the first vaccine dose of two-dose or three dose primary vaccination in study HAB-084. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

13.  Primary:   Anti-HBs Anamnestic Response.   [ Time Frame: One month after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

14.  Secondary:   Number of Subjects With Anti-HAV Antibody Concentrations Above or Equal to Specified Value and Geometric Mean Concentrations (GMCs).   [ Time Frame: Before and one month after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

15.  Secondary:   Number of Subjects With Anti-HBs Antibody Concentrations Above or Equal to Specified Value and GMCs.   [ Time Frame: Before and one month after the combined hepatitis A and/or hepatitis B vaccine challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

16.  Secondary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

17.  Secondary:   Number of Subjects With Solicited General Symptoms.   [ Time Frame: During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

18.  Secondary:   Number of Subjects With Unsolicited Symptoms.   [ Time Frame: During the 31-day (Day 0 to 30) follow-up period after the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No

19.  Secondary:   Number of Subjects With Serious Adverse Events   [ Time Frame: One month after the administration of the challenge dose. ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00875485     History of Changes
Other Study ID Numbers: 110699, 110700, 110701, 110702, 110703, 110704
Study First Received: April 2, 2009
Results First Received: May 27, 2010
Last Updated: August 2, 2012
Health Authority: Belgium: Direction Générale de la Protection de la Santé Publique Médicaments
Czech: State Institute for Drug Control