ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier

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.
ClinicalTrials.gov Identifier: NCT02581410
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : September 26, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Herpes Zoster
Intervention: Biological: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)

  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
No text entered.

Reporting Groups
  Description
GSK1437173A Group Subjects above or equal to (≥) 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Control Group Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.

Participant Flow for 2 periods

Period 1:   Vaccination Phase
    GSK1437173A Group   Control Group
STARTED   215   215 
COMPLETED   213   212 
NOT COMPLETED   2   3 
Adverse Event                2                1 
Withdrawal by Subject                0                1 
Migrated/moved from study area                0                1 

Period 2:   End of Study Phase
    GSK1437173A Group   Control Group
STARTED   215   215 
COMPLETED   210   204 
NOT COMPLETED   5   11 
Adverse Event                4                3 
Withdrawal by Subject                1                2 
Migrated/moved from study area                0                3 
Lost to Follow-up                0                2 
Other-transfer of subject not completed                0                1 



  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 ≥ 65 years of age who received Zostavax vaccine ≥ 5 years earlier and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2) in this study.
Control Group Subjects ≥ 65 years of age who never received Zostavax vaccine and received 2 doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given at Month 2).in this study.
Total Total of all reporting groups

Baseline Measures
   GSK1437173A Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 215   215   430 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.1  (4.5)   70.8  (4.6)   70.9  (4.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      109  50.7%      111  51.6%      220  51.2% 
Male      106  49.3%      104  48.4%      210  48.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White - Caucasian / European Heritage       
White - Caucasian / European Heritage   215   215   430 


  Outcome Measures

1.  Primary:   Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations   [ Time Frame: One month after dose 2, at Month 3 ]

2.  Primary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) period after each dose. ]

3.  Primary:   Number of Days With Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) period after each dose. ]

4.  Primary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) period after each dose. ]

5.  Primary:   Number of Days With Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) period after each dose. ]

6.  Primary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)   [ Time Frame: During the 30-day (Days 0-29) period after each dose. ]

7.  Primary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs)   [ Time Frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3) ]

8.  Primary:   Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)   [ Time Frame: From first vaccination (Month 0) up to 30 days post last vaccination (Month 3) ]

9.  Secondary:   Anti-gE Ab Concentrations   [ Time Frame: At Months 0, 1, 3 and 14. ]

10.  Secondary:   Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells   [ Time Frame: At Months 0, 1, 3 and 14. ]

11.  Secondary:   Number of Subjects With Any and Related SAEs   [ Time Frame: From 30 days post last vaccination (Month 3) until study end at Month 14 ]

12.  Secondary:   Number of Subjects With Any pIMDs   [ Time Frame: From 30 days post last vaccination (Month 3) until study end at Month 14 ]


  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


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02581410     History of Changes
Other Study ID Numbers: 201198
First Submitted: October 19, 2015
First Posted: October 21, 2015
Results First Submitted: August 29, 2017
Results First Posted: September 26, 2017
Last Update Posted: August 28, 2018