Text Size

Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197119
First received: September 14, 2005
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
Results First Received: July 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Hepatitis B
Hepatitis A
Interventions: Biological: Twinrix™ Adult
Biological: Twinrix™ Junior

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
At the time of initiation of the long-term follow-up study, the investigators contacted the subjects who had consented to participate in the long-term follow-up studies. At each subsequent visit, subjects who were present at the previous long-term blood sampling time points were contacted again.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group Twinrix Junior Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
Group Twinrix Adult Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.

Participant Flow for 5 periods

 Period 1:   Year 6
    Group Twinrix Junior     Group Twinrix Adult  
STARTED     126     118  
COMPLETED     126     118  
NOT COMPLETED     0     0  

Period 2:   Year 7
    Group Twinrix Junior     Group Twinrix Adult  
STARTED     122 [1]   114 [1]
COMPLETED     122     114  
NOT COMPLETED     0     0  
[1] 4 subjects who participated in the Year 6 follow-up time point did not return for this time point.

Period 3:   Year 8
    Group Twinrix Junior     Group Twinrix Adult  
STARTED     122     115 [1]
COMPLETED     122     115  
NOT COMPLETED     0     0  
[1] One additional subject (compared to Year 7) participated in the current follow-up time point.

Period 4:   Year 9
    Group Twinrix Junior     Group Twinrix Adult  
STARTED     121 [1]   114 [1]
COMPLETED     121     114  
NOT COMPLETED     0     0  
[1] One subject participating in the Year 8 time point did not return for the current time point.

Period 5:   Year 10
    Group Twinrix Junior     Group Twinrix Adult  
STARTED     120 [1]   108 [2]
COMPLETED     120     108  
NOT COMPLETED     0     0  
[1] One subject participating in the Year 9 time point did not return for the current time point.
[2] Six subjects participating in the Year 9 time point did not return for the current time point.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Group Twinrix Junior Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
Group Twinrix Adult Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Total Total of all reporting groups

Baseline Measures
    Group Twinrix Junior     Group Twinrix Adult     Total  
Number of Participants  
[units: participants]
 		  126     118     244  
Age [1]
[units: years]
Mean ± Standard Deviation 		  19.4  ± 1.04     19.4  ± 1.12     19.4  ± 1.08  
Gender  
[units: subjects]
 		     
Female     62     61     123  
Male     64     57     121  
[1] Subjects' mean age at Year 6, the time of first enrollment into the long-term follow-up phase of the study.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value   [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value   [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination ]
  Show Outcome Measure 2

3.  Primary:   Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)   [ Time Frame: From Year 6 through to Year 10 ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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 by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00197119     History of Changes
Other Study ID Numbers: 100566, 100567, 100568, 100569, 100570
Study First Received: September 14, 2005
Results First Received: July 2, 2009
Last Updated: November 3, 2011
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines