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Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00693706
First received: June 2, 2008
Last updated: February 7, 2013
Last verified: February 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Influenza Vaccines
Seasonal Influenza
Interventions: Biological: Trivalent influenza vaccine GSK 138842A
Biological: Fluarix

  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
GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    GSK 1388442A Group     Fluarix Group  
STARTED     101     99  
COMPLETED     101     98  
NOT COMPLETED     0     1  
Protocol Violation                 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.
No text entered.

Reporting Groups
  Description
GSK 1388442A Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    GSK 1388442A Group     Fluarix Group     Total  
Number of Participants  
[units: participants]
  101     99     200  
Age  
[units: Years]
Mean ± Standard Deviation
  33.1  ± 10.24     31.6  ± 9.77     32.4  ± 10.0  
Gender  
[units: subjects]
     
Female     54     52     106  
Male     47     47     94  



  Outcome Measures
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1.  Primary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post vaccination period ]

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

3.  Primary:   Number of Subjects With Medically Attended Adverse Events (MAEs).   [ Time Frame: During the entire study period (Days 0-182) ]

4.  Primary:   Number of Subjects With New Onset of Chronic Diseases (NOCDs).   [ Time Frame: During the entire study period (Days 0-182) ]

5.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs).   [ Time Frame: During the 90-day (Days 0-89) post-vaccination period ]

6.  Primary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (Days 0-182) ]

7.  Primary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies for 3 Strains of Influenza Disease.   [ Time Frame: At Day 21 ]

8.  Primary:   Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.   [ Time Frame: At Day 21 ]

9.  Primary:   Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.   [ Time Frame: At Day 21 ]

10.  Primary:   Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.   [ Time Frame: At Day 0 and Day 21 ]


  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


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00693706     History of Changes
Other Study ID Numbers: 110127
Study First Received: June 2, 2008
Results First Received: December 19, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration