Trial record 1 of 174862 for:    ALL
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Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00814489
First received: December 23, 2008
Last updated: July 18, 2013
Last verified: July 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Diseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae
Haemophilus Influenzae-Streptococcus Pneumoniae Vaccine
Interventions: Biological: GSK2231395A
Biological: Engerix-B

  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
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
GSK2254233A Group Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK2254232A Group Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Engerix Group Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    GSK2254233A Group     GSK2254232A Group     Engerix Group  
STARTED     15     17     8  
COMPLETED     13     17     7  
NOT COMPLETED     2     0     1  
Unspecified                 2                 0                 1  



  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.
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Reporting Groups
  Description
GSK2254233A Group Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
GSK2254232A Group Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Engerix Group Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    GSK2254233A Group     GSK2254232A Group     Engerix Group     Total  
Number of Participants  
[units: participants]
  15     17     8     40  
Age  
[units: Years]
Mean ± Standard Deviation
  26.9  ± 5.91     24.3  ± 3.69     26.6  ± 5.50     25.7  ± 5.01  
Gender  
[units: Subjects]
       
Female     7     10     5     22  
Male     8     7     3     18  



  Outcome Measures
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1.  Primary:   Number of Subjects With Any Solicited Local and General Symptoms   [ Time Frame: During a 7-day follow up period after any vaccination ]

2.  Primary:   Number of Subjects With Any Unsolicited Adverse Events (AE)   [ Time Frame: During a 30-day (Days 0-29) follow up period after any vaccination ]

3.  Primary:   Number of Subjects With Any Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 to Day 420 ]

4.  Primary:   Number of Subjects With Any Biochemical Laboratory Abnormalities   [ Time Frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420 ]

5.  Primary:   Number of Subjects With Any Hematological Laboratory Abnormalities   [ Time Frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. ]

6.  Primary:   Number of Subjects With Any Hematological Laboratory Abnormalities   [ Time Frame: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420. ]

7.  Secondary:   Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)   [ Time Frame: Days 0, 30, 60, 90, 180 and 420. ]

8.  Secondary:   Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.   [ Time Frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. ]

9.  Secondary:   Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.   [ Time Frame: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480. ]


  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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00814489     History of Changes
Other Study ID Numbers: 112076
Study First Received: December 23, 2008
Results First Received: December 19, 2012
Last Updated: July 18, 2013
Health Authority: Sweden: Medical Products Agency