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Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents

This study has been completed.
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00950612
First received: July 23, 2009
Last updated: November 9, 2016
Last verified: October 2016
Results First Received: November 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Tuberculosis
Interventions: Biological: GSK's investigational vaccine 692342
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GSK692342 Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
Placebo Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.

Participant Flow:   Overall Study
    GSK692342 Group   Placebo Group
STARTED   40   20 
COMPLETED   40   20 
NOT COMPLETED   0   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
GSK692342 Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
Placebo Group Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
Total Total of all reporting groups

Baseline Measures
   GSK692342 Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   20   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.8  (1.20)   14.9  (1.12)   14.83  (1.17) 
Gender 
[Units: Participants]
Count of Participants
     
Female      18  45.0%      11  55.0%      29  48.3% 
Male      22  55.0%      9  45.0%      31  51.7% 


  Outcome Measures
  Show All Outcome Measures

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

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

3.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]

4.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 up to Day 210) ]

5.  Primary:   Number of Subjects With Normal Biochemical and Haematological Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

6.  Primary:   Number of Subjects With Normal Haematological Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

7.  Primary:   Number of Subjects With Biochemical and Haematological Above Normal Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

8.  Primary:   Number of Subjects With Haematological Levels Above Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

9.  Primary:   Number of Subjects With Biochemical and Haematological Below Normal Levels   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

10.  Primary:   Number of Subjects With Haematological Levels Below Normal   [ Time Frame: At Day 0, 7, 30, 37 and 60 ]

11.  Secondary:   Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines   [ Time Frame: At Day 0, 7, 30, 37, 60 and 210 ]

12.  Secondary:   Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines   [ Time Frame: At Day 0, 7, 30, 37, 60 and 210 ]

13.  Secondary:   Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines   [ Time Frame: At Day 0, 7, 30, 37, 60 and 210 ]

14.  Secondary:   Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines   [ Time Frame: At Day 0, 7, 30, 37, 60 and 210 ]

15.  Secondary:   Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines   [ Time Frame: At Day 0, 7, 30, 37, 60 and 210 ]

16.  Secondary:   Anti-M72 Specific Antibody Concentrations   [ Time Frame: At Day 0, 30, 60 and 210 ]


  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: NCT00950612     History of Changes
Other Study ID Numbers: 112898
Study First Received: July 23, 2009
Results First Received: November 9, 2016
Last Updated: November 9, 2016