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Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165229
First Posted: July 19, 2010
Last Update Posted: November 20, 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 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: Herpes Zoster Vaccine GSK1437173A
Biological: Placebo

  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
Out of the 14819 subjects originally enrolled in the study, only 13900 subjects have been vaccinated and included in the Total Vaccinated Cohort.

Reporting Groups
  Description
Zoster-022 GSK1437173A Group Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Zoster-022 Placebo Group Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

Participant Flow:   Overall Study
    Zoster-022 GSK1437173A Group   Zoster-022 Placebo Group
STARTED   6950   6950 
COMPLETED   5770   5761 
NOT COMPLETED   1180   1189 
Unknown completion status                0                1 
Serious Adverse Event                459                487 
Non-Serious Adverse Event                47                15 
Protocol Violation                10                12 
Withdrawal by Subject                396                403 
Migrated/moved from study area                51                46 
Lost to Follow-up                124                138 
Suspected HZ Episode                0                2 
No reason from the subject                0                1 
Page entered in error                0                1 
Patient not eligible                0                1 
Health issues                61                56 
Site closure                18                20 
Personal reason                10                4 
Investigator decision                0                2 
Sponsor study termination                1                0 
Missed visit                1                0 
Lack of time                1                0 
Screening criteria unmet                1                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
Zoster-022 GSK1437173A Group Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
Zoster-022 Placebo Group Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Total Total of all reporting groups

Baseline Measures
   Zoster-022 GSK1437173A Group   Zoster-022 Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 6950   6950   13900 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.6  (4.7)   75.6  (4.7)   75.6  (4.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3789  54.5%      3836  55.2%      7625  54.9% 
Male      3161  45.5%      3114  44.8%      6275  45.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Geographic ancestry       
African Heritage / African American      79   1.1%      67   1.0%      146   1.1% 
American Indian or Alaskan Native      1   0.0%      8   0.1%      9   0.1% 
Asian - Central/South Asian Heritage      3   0.0%      6   0.1%      9   0.1% 
Asian - East Asian Heritage      907  13.1%      908  13.1%      1815  13.1% 
Asian - Japanese Heritage      298   4.3%      300   4.3%      598   4.3% 
Asian - South East Asian Heritage      8   0.1%      4   0.1%      12   0.1% 
Native Hawaiian or Other Pacific Islander      3   0.0%      3   0.0%      6   0.0% 
White - Arabic / North African Heritage      40   0.6%      47   0.7%      87   0.6% 
White - Caucasian / European Heritage      5307  76.4%      5301  76.3%      10608  76.3% 
Other      304   4.4%      306   4.4%      610   4.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Any Episodes of Herpes Zoster (HZ)   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

2.  Primary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

3.  Primary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

4.  Secondary:   Number of Subjects With Post-herpetic Neuralgia (PHN)   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

5.  Secondary:   Number of Days With Severe ‘Worst’ HZ-associated Pain   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

6.  Secondary:   Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

7.  Secondary:   Number of Subjects With Overall Mortality and HZ-related Mortality   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

8.  Secondary:   Number of Subjects With Confirmed HZ Episode Related Hospitalizations   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

9.  Secondary:   Number of Subjects With HZ Related Complications   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

10.  Secondary:   Number of Subjects Receiving Pain Medication Associated With HZ   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

11.  Secondary:   Number of Days With Pain Medication Associated With HZ   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

12.  Secondary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

13.  Secondary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

14.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 30 days (Days 0-29) after each vaccination ]

15.  Secondary:   Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)   [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0) ]

16.  Secondary:   Number of Subjects With Potential Immune Mediated Diseases (pIMDs)   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

17.  Secondary:   Number of Subjects With Medically Attended Events (MAEs)   [ Time Frame: From Month 0 to Month 8 post-vaccination ]

18.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

19.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

20.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe ‘Worst’ HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

21.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Reduction of Duration of Severe ‘Worst’ HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

22.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

23.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

24.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Unsolicited AEs in Subjects ≥ 70 YOA   [ Time Frame: Within 30 days (Days 0 - 29) after each vaccination ]

25.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Related and Fatal SAEs   [ Time Frame: From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0) ]

26.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any pIMDs   [ Time Frame: During the entire study period (3 to 5 year period following Day 0) ]

27.  Secondary:   Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Medically Attended Events (MAEs)   [ Time Frame: From Month 0 to Month 8 post-vaccination ]


  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


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01165229     History of Changes
Other Study ID Numbers: 113077
2009-015791-94 ( EudraCT Number )
First Submitted: July 15, 2010
First Posted: July 19, 2010
Results First Submitted: May 9, 2017
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017