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Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years

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ClinicalTrials.gov Identifier: NCT01777321
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : January 6, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel 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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
SC GSK1437173A Group Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
IM GSK1437173A Group Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.

Participant Flow:   Overall Study
    SC GSK1437173A Group   IM GSK1437173A Group
STARTED   30   30 
COMPLETED   30   29 
NOT COMPLETED   0   1 
Withdrawal by Subject                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
SC GSK1437173A Group Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
IM GSK1437173A Group Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
Total Total of all reporting groups

Baseline Measures
   SC GSK1437173A Group   IM GSK1437173A Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (7.59)   62.2  (7.83)   61.90  (7.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  50.0%      15  50.0%      30  50.0% 
Male      15  50.0%      15  50.0%      30  50.0% 


  Outcome Measures

1.  Primary:   Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)   [ Time Frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) ]

2.  Primary:   Anti-gE Antibody Concentrations   [ Time Frame: Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) ]

3.  Primary:   Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations   [ Time Frame: At two months after Dose 1 (M2) and one month after Dose 2 (M3) ]

4.  Primary:   Descriptive Statistics of Anti-gE Antibody Concentrations   [ Time Frame: Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3) ]

5.  Primary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses ]

6.  Primary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses ]

7.  Primary:   Mean Number of Days With Local Symptoms   [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) ]

8.  Primary:   Mean Number of Days With General Symptoms   [ Time Frame: During the 7 day (Days 0-6) post vaccination, after each dose (D) ]

9.  Primary:   Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)   [ Time Frame: From Month 0 to Month 3 ]

10.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within 30 days (Days 0-29) post vaccination period ]

11.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Month 0 to Month 3 ]

12.  Secondary:   Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL   [ Time Frame: At Month 14 ]

13.  Secondary:   Anti-gE Antibody Concentrations   [ Time Frame: At Month 14 ]

14.  Secondary:   Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations   [ Time Frame: Twelve Months after Dose 2 (M14) ]

15.  Secondary:   Number of Subjects With pIMDs   [ Time Frame: Up to Month 14 post vaccination period ]

16.  Secondary:   Number of Subjects With SAEs   [ Time Frame: Up to Month 14 post vaccination period ]


  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: NCT01777321     History of Changes
Other Study ID Numbers: 116760
2012-005671-14 ( EudraCT Number )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: November 8, 2016
Results First Posted: January 6, 2017
Last Update Posted: September 24, 2018