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Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

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ClinicalTrials.gov Identifier: NCT01610414
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: Herpes Zoster vaccine GSK1437173A
Biological: Placebo

  Participant Flow

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
Some of the enrolled subjects were allocated subject numbers, but were not administered all doses of study vaccine, hence they did not start the study.

Reporting Groups
  Description
GSK1437173A Group Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Placebo Group Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.

Participant Flow for 3 periods

Period 1:   Study Start - Month 13
    GSK1437173A Group   Placebo Group
STARTED   922   924 
COMPLETED   807   795 
NOT COMPLETED   115   129 
Serious Adverse Event                65                67 
Adverse Event                14                14 
Protocol Violation                3                1 
Withdrawal by Subject                23                30 
Migrated/moved from study area                2                4 
Lost to Follow-up                4                6 
Suspected HZ episode                1                3 
Other reasons for withdrawal                3                4 

Period 2:   Month 13 - Month 25
    GSK1437173A Group   Placebo Group
STARTED   922   924 
COMPLETED   857   854 
NOT COMPLETED   65   70 
Serious Adverse Event                35                38 
Adverse Event                8                4 
Withdrawal by Subject                7                8 
Migrated/moved from study area                4                2 
Protocol Violation                0                2 
Lost to Follow-up                5                9 
Other reasons for withdrawal                6                7 

Period 3:   After Month 25
    GSK1437173A Group   Placebo Group
STARTED   922   924 
COMPLETED   874   871 
NOT COMPLETED   48   53 
Study end not reached                48                53 



  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.
No text entered.

Reporting Groups
  Description
GSK1437173A Group Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Placebo Group Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule.
Total Total of all reporting groups

Baseline Measures
   GSK1437173A Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 922   924   1846 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.8  (11.7)   55.1  (11.4)   55.0  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      342  37.1%      346  37.4%      688  37.3% 
Male      580  62.9%      578  62.6%      1158  62.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Geographic ancestry       
African Heritage/African American      15   1.6%      25   2.7%      40   2.2% 
American Indian or Alaskan Native      2   0.2%      0   0.0%      2   0.1% 
Asian - Central/South Asian Heritage      6   0.7%      5   0.5%      11   0.6% 
Asian - East Asian Heritage      83   9.0%      91   9.8%      174   9.4% 
Asian - Japanese Heritage      43   4.7%      38   4.1%      81   4.4% 
Asian - South East Asian Heritage      18   2.0%      16   1.7%      34   1.8% 
White - Arabic/North African Heritage      9   1.0%      12   1.3%      21   1.1% 
White - Caucasian/European Heritage      715  77.5%      712  77.1%      1427  77.3% 
Mixed Origin      31   3.4%      25   2.7%      56   3.0% 


  Outcome Measures

1.  Primary:   Number of Subjects With Confirmed Herpes Zoster (HZ) Episode   [ Time Frame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) ]

2.  Secondary:   Duration of ‘Worst’ HZ-associated Pain   [ Time Frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period ]

3.  Secondary:   Number of Subjects With Confirmed HZ-associated Complications   [ Time Frame: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months) ]

4.  Secondary:   Number of Subjects With Postherpetic Neuralgia (PHN)   [ Time Frame: From Month 0 until study end (21 months median follow-up) ]

5.  Secondary:   Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects   [ Time Frame: At Months 0, 1, 2, 13 and 25 ]

6.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

7.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

8.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]

9.  Secondary:   Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)   [ Time Frame: From Month 0 up to 365 days post last vaccination ]

10.  Secondary:   Number of Subjects With Any Relapse   [ Time Frame: From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) ]

11.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo   [ Time Frame: From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years) ]

12.  Secondary:   Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination   [ Time Frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years) ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: NCT01610414     History of Changes
Other Study ID Numbers: 115523
2012-000138-20 ( EudraCT Number )
First Submitted: May 31, 2012
First Posted: June 4, 2012
Results First Submitted: November 3, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018