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Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291876
First received: February 14, 2006
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
Results First Received: December 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis A
Intervention: Biological: Havrix™

  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

Participant Flow and Baseline measures are given for the Month 198 time point in order to account for all subjects participating in this long-term follow-up study.

Note that not all subjects returned and participated in each of the intermediate follow-up time points.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

The Long-Term (LT) Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study.

The Long Term According-to-Protocol (LT-ATP) cohort for immunogenicity included subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study.

Reporting Groups
  Description
Havrix Group Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.

Participant Flow:   Overall Study
    Havrix Group  
STARTED     135  
COMPLETED     135  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Havrix Group Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.

Baseline Measures
    Havrix Group  
Number of Participants  
[units: participants]
 		  135  
Age  
[units: years]
Mean ± Standard Deviation 		  46.3  ± 5.35  
Gender  
[units: participants]
 		 
Female     103  
Male     32  



  Outcome Measures
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1.  Primary:   Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration   [ Time Frame: At Months 138, 150, 162, 174, 186, 198, 210, 222 and 234 ]
  Show Outcome Measure 1

2.  Primary:   Number of Seropositive Subjects Against Hepatitis A Virus   [ Time Frame: At Months 138, 150, 162, 174, 186, 198, 210, 222 and 234 ]
  Show Outcome Measure 2

3.  Secondary:   Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration   [ Time Frame: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: During the 4-day (Days 0-3) follow-up period after additional vaccination ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: During the 4-day (Days 0-3) follow-up period after additional vaccination ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During the 30-day follow-up period after additional vaccination ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy   [ Time Frame: At Months 138, 150, 162, 174, 186, 198, 210, 222 and 234 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination   [ Time Frame: During the 30-day follow-up period after additional vaccination ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Reporting Pregnancies After Additional Vaccination   [ Time Frame: At Months 186 and 198 ]
  Show Outcome Measure 9

10.  Primary:   Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration   [ Time Frame: At Month 246 ]
Results not yet posted.   Anticipated Posting Date:   11/2014   Safety Issue:   No

11.  Primary:   Number of Seropositive Subjects Against Hepatitis A Virus   [ Time Frame: At Month 246 ]
Results not yet posted.   Anticipated Posting Date:   11/2014   Safety Issue:   No

12.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigator as Related to Primary Study Vaccination, Procedures or Lack of Vaccine Efficacy   [ Time Frame: At Month 246 ]
Results not yet posted.   Anticipated Posting Date:   11/2014   Safety Issue:   No

13.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) After Additional Vaccination   [ Time Frame: During the 30-day follow-up period after additional vaccination up to Month 246 ]
Results not yet posted.   Anticipated Posting Date:   11/2014   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
For 5 subjects at Month 234, serum sample tubes were broken. Due to risk of contamination, anti-HAV concentrations analyses were not performed for these subjects, who were excluded in the LT-ATP cohort for immunogenicity analysis at Month 234.  


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


Publications:
Van Herck K et al. (2011) Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 83(11):1885-1891.

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00291876     History of Changes
Other Study ID Numbers: 100571 (M138), 100572 (M150), 100573 (M162), 100574 (M174), 100575 (M186), 110677 (M198), 110678 (M210), 110679, 110680, 110681
Study First Received: February 14, 2006
Results First Received: December 10, 2009
Last Updated: May 16, 2013
Health Authority: Belgium: Institutional Review Board