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Trial record 34 of 465 for:    Shingles

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster

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: NCT01827839
Recruitment Status : Completed
First Posted : April 10, 2013
Results First Posted : March 7, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Herpes Zoster
Intervention: Biological: Herpes Zoster vaccine (GSK1437173A)

  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 who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.

Participant Flow:   Overall Study
    GSK1437173A Group
STARTED   96 
COMPLETED   93 
NOT COMPLETED   3 
Adverse Event                1 
Consent Withdrawal                2 



  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 who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.

Baseline Measures
   GSK1437173A Group 
Overall Participants Analyzed 
[Units: Participants]
 96 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.9  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      63  65.6% 
Male      33  34.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White - Caucasian/European   92 
Asian - Central/South Asian   2 
Asian - Japanese   1 
White - Arabic /North African   1 


  Outcome Measures

1.  Primary:   Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA   [ Time Frame: At Month 3 ]

2.  Primary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose and across doses ]

3.  Primary:   Number of Days With Solicited Local Symptoms   [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose ]

4.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose and across doses ]

5.  Primary:   Number of Days With Solicited General Symptoms   [ Time Frame: Within 7 days (Day 0-6) after each vaccine dose ]

6.  Primary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Within 30 days (Days 0-29) after each vaccination ]

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

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

9.  Secondary:   Anti-gE Antibody Concentrations   [ Time Frame: At Month 0 and at Month 3 ]

10.  Secondary:   Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value   [ Time Frame: At Month 0 and at Month 3 ]

11.  Secondary:   Number of Subjects With SAEs   [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. Month 14) ]

12.  Secondary:   Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)   [ Time Frame: Starting after 30 days post last vaccination until study end (i.e. 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: NCT01827839     History of Changes
Other Study ID Numbers: 116796
2012-003643-30 ( EudraCT Number )
First Submitted: March 28, 2013
First Posted: April 10, 2013
Results First Submitted: December 8, 2016
Results First Posted: March 7, 2017
Last Update Posted: November 27, 2017