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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:
ClinicalTrials.gov Identifier:
NCT00291876
First Posted: February 15, 2006
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: December 10, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Hepatitis A
Intervention: Biological: Havrix™

  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
Participant Flow and Baseline Measures are given for each of the follow-up time points- Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246. 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 for 10 periods

Period 1:   Month 138
    Havrix Group
STARTED   107 
COMPLETED   107 
NOT COMPLETED   0 

Period 2:   Month 150
    Havrix Group
STARTED   117 
COMPLETED   117 
NOT COMPLETED   0 

Period 3:   Month 162
    Havrix Group
STARTED   127 
COMPLETED   127 
NOT COMPLETED   0 

Period 4:   Month 174
    Havrix Group
STARTED   127 
COMPLETED   127 
NOT COMPLETED   0 

Period 5:   Month 186
    Havrix Group
STARTED   129 
COMPLETED   129 
NOT COMPLETED   0 

Period 6:   Month 198
    Havrix Group
STARTED   135 
COMPLETED   135 
NOT COMPLETED   0 

Period 7:   Month 210
    Havrix Group
STARTED   124 
COMPLETED   124 
NOT COMPLETED   0 

Period 8:   Month 222
    Havrix Group
STARTED   114 
COMPLETED   114 
NOT COMPLETED   0 

Period 9:   Month 234
    Havrix Group
STARTED   110 
COMPLETED   110 
NOT COMPLETED   0 

Period 10:   Month 246
    Havrix Group
STARTED   116 
COMPLETED   116 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Baseline Measures are given for each of the follow-up time points- Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246. Note that not all subjects returned and participated in each of the intermediate follow-up time points.

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] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 107 
   42.2  (5.44) 
[1] The baseline measure data here corresponds to Month 138
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 117 
   42.9  (5.35) 
[1] The baseline measure data here corresponds to Month 150
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 127 
   43.4  (5.34) 
[1] The baseline measure data here corresponds to Month 162
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 127 
   44.5  (5.37) 
[1] The baseline measure data here corresponds to Month 174
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 129 
   45.4  (5.39) 
[1] The baseline measure data here corresponds to Month 186
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 135 
   46.3  (5.35) 
[1] The baseline measure data here corresponds to Month 198
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 124 
   47.6  (5.39) 
[1] The baseline measure data here corresponds to Month 210
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 114 
   48.5  (5.39) 
[1] The baseline measure data here corresponds to Month 222
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 110 
   49.6  (5.42) 
[1] The baseline measure data here corresponds to Month 234
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 116 
   50.8  (5.34) 
[1] The baseline measure data here corresponds to Month 246
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 107 
Female      77  72.0% 
Male      30  28.0% 
[1] The baseline measure data here corresponds to Month 138
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 117 
Female      87  74.4% 
Male      30  25.6% 
[1] The baseline measure data here corresponds to Month 150
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 127 
Female      93  73.2% 
Male      34  26.8% 
[1] The baseline measure data here corresponds to Month 162
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 127 
Female      94  74.0% 
Male      33  26.0% 
[1] The baseline measure data here corresponds to Month 174
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 129 
Female      98  76.0% 
Male      31  24.0% 
[1] The baseline measure data here corresponds to Month 186
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 135 
Female      103  76.3% 
Male      32  23.7% 
[1] The baseline measure data here corresponds to Month 198
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 124 
Female      93  75.0% 
Male      31  25.0% 
[1] The baseline measure data here corresponds to Month 210
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 114 
Female      83  72.8% 
Male      31  27.2% 
[1] The baseline measure data here corresponds to Month 222
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 110 
Female      81  73.6% 
Male      29  26.4% 
[1] The baseline measure data here corresponds to Month 234
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.
Sex: Female, Male [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 116 
Female      86  74.1% 
Male      30  25.9% 
[1] The baseline measure data here corresponds to Month 246
[2] Note that not all subjects returned and participated in each of the intermediate follow-up time points.


  Outcome Measures
  Show All Outcome Measures

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
  Hide 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.


  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 )
First Submitted: February 14, 2006
First Posted: February 15, 2006
Results First Submitted: December 10, 2009
Results First Posted: March 8, 2010
Last Update Posted: November 29, 2017