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Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295320
First Posted: February 14, 2011
Last Update Posted: October 5, 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: May 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Herpes Zoster
Intervention: Procedure: Blood sample

  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
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Reporting Groups
  Description
GSK1437173A Group Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).

Participant Flow:   Overall Study
    GSK1437173A Group
STARTED   129 
COMPLETED   119 
NOT COMPLETED   10 
Adverse Event                2 
Lost to Follow-up                4 
Withdrawal by Subject                2 
Subject was bedridden                1 
Unable to travel                1 



  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
GSK1437173A Group Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).

Baseline Measures
   GSK1437173A Group 
Overall Participants Analyzed 
[Units: Participants]
 129 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.8  (4.96) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      78  60.5% 
Male      51  39.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White - Caucasian/European Heritage   128 
African Heritage/African American   1 


  Outcome Measures
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1.  Primary:   Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells   [ Time Frame: Month 48 ]

2.  Primary:   Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells   [ Time Frame: Month 60 ]

3.  Primary:   Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells   [ Time Frame: Month 72 ]

4.  Primary:   Antigen-specific Antibody (Ab) Concentrations   [ Time Frame: Month 48 ]

5.  Primary:   Antigen-specific Antibody (Ab) Concentrations   [ Time Frame: Month 60 ]

6.  Primary:   Antigen-specific Antibody (Ab) Concentrations   [ Time Frame: Month 72 ]

7.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation   [ Time Frame: Month 48 to Month 72 ]

8.  Secondary:   Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented   [ Time Frame: Month 0 to Month 72 ]

9.  Secondary:   Number of Subjects With Any Fatal SAEs   [ Time Frame: Month 48 to Month 72 ]

10.  Secondary:   Number of Subjects With Any Suspected Cases of HZ Episodes   [ Time Frame: Month 48 to Month 72 ]

11.  Secondary:   Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented   [ Time Frame: Month 48 to Month 72 ]

12.  Secondary:   Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented   [ Time Frame: Month 48 to Month 72 ]


  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
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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.


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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01295320     History of Changes
Other Study ID Numbers: 114825
First Submitted: February 11, 2011
First Posted: February 14, 2011
Results First Submitted: May 11, 2017
Results First Posted: October 5, 2017
Last Update Posted: October 5, 2017