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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291876
First received: February 14, 2006
Last updated: January 2, 2017
Last verified: December 2016
Results First Received: December 10, 2009  
Study Type: Interventional
Study Design: 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 (Year 16.5) time point, which had the highest enrollment, 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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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.
In this study,107 subjects were enrolled at M138,117 subjects at M150,127 subjects at M162 and M174, 129 subjects at M186,135 subjects at M198,124 subjects at M210,114 subjects at M222,110 subjects at M234 and 116 subjects at M246. The highest enrollment has been mentioned to account for all subjects participating in this long-term follow-up study.

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 
Overall Participants Analyzed 
[Units: Participants]
 135 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 46.3  (5.35) 
[1] The baseline measure data here corresponds to Month 198
Gender [1] 
[Units: Participants]
Count of Participants
 
Female      103  76.3% 
Male      32  23.7% 
[1] The baseline measure data here corresponds to Month 198


  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, 234 and 246 ]

2.  Primary:   Number of Seropositive Subjects Against Hepatitis A Virus   [ Time Frame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246 ]

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 ]

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

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

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

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, 234 and 246 ]

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00291876     History of Changes
Other Study ID Numbers: 100571 (M138)
100572 (M150) ( Other Identifier: GSK )
100573 (M162) ( Other Identifier: GSK )
100574 (M174) ( Other Identifier: GSK )
100575 (M186) ( Other Identifier: GSK )
110677 (M198) ( Other Identifier: GSK )
110678 (M210) ( Other Identifier: GSK )
110679 ( Other Identifier: GSK )
110680 ( Other Identifier: GSK )
110681 ( Other Identifier: GSK )
Study First Received: February 14, 2006
Results First Received: December 10, 2009
Last Updated: January 2, 2017