Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00684671
First received: May 23, 2008
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: October 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Viral Hepatitis Vaccines
Hepatitis B
Hepatitis A
Interventions: Biological: Twinrix
Biological: Engerix-B
Biological: Havrix
Biological: HBVAXPRO
Biological: Vaqta

  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
No text entered.

Reporting Groups
  Description
Twinrix Group Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
Engerix + Havrix Group Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
HB VAX PRO + Vaqta Group Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).

Participant Flow:   Overall Study
    Twinrix Group     Engerix + Havrix Group     HB VAX PRO + Vaqta Group  
STARTED     172     170     164  
COMPLETED     169     170     164  
NOT COMPLETED     3     0     0  
Adverse Event                 1                 0                 0  
Lost to Follow-up                 1                 0                 0  
Alcoholic dependance                 1                 0                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Twinrix Group Subjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
Engerix + Havrix Group Subjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
HB VAX PRO + Vaqta Group Subjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
Total Total of all reporting groups

Baseline Measures
    Twinrix Group     Engerix + Havrix Group     HB VAX PRO + Vaqta Group     Total  
Number of Participants  
[units: participants]
  172     170     164     506  
Age  
[units: years]
Mean ± Standard Deviation
  58.4  ± 8.70     59.5  ± 10.18     59.1  ± 9.16     59.0  ± 9.36  
Gender  
[units: Subjects]
       
Female     85     83     85     253  
Male     87     87     79     253  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies   [ Time Frame: One month after the challenge dose. ]

2.  Primary:   Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies   [ Time Frame: One month after the challenge dose. ]

3.  Secondary:   Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations   [ Time Frame: Prior to administration of challenge dose ]

4.  Secondary:   Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations   [ Time Frame: Two weeks and one month after the challenge dose ]

5.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: During the 4-day follow-up period after the challenge dose. ]

6.  Secondary:   Number of Subjects Reporting Unsolicited Symptoms   [ Time Frame: During the 31-day follow-up period after the challenge dose. ]

7.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination   [ Time Frame: Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year) ]

8.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During one month following the administration of the challenge dose ]


  Serious Adverse Events


  Other Adverse Events


  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 by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00684671     History of Changes
Other Study ID Numbers: 111572
Study First Received: May 23, 2008
Results First Received: October 29, 2009
Last Updated: June 14, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products