Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00718120
First received: July 17, 2008
Last updated: October 8, 2009
Last verified: October 2009
Results First Received: July 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Fluviral®

  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
Fluviral Adult Group Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
Fluviral Elderly Group Subjects aged more than 60 years received a single dose of Fluviral® vaccine.

Participant Flow:   Overall Study
    Fluviral Adult Group     Fluviral Elderly Group  
STARTED     55     55  
COMPLETED     55     55  
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
Fluviral Adult Group Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
Fluviral Elderly Group Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Total Total of all reporting groups

Baseline Measures
    Fluviral Adult Group     Fluviral Elderly Group     Total  
Number of Participants  
[units: participants]
  55     55     110  
Age  
[units: years]
Mean ± Standard Deviation
  40.1  ± 12.16     66.4  ± 4.61     53.2  ± 16.08  
Gender  
[units: subjects]
     
Female     36     35     71  
Male     19     20     39  



  Outcome Measures
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1.  Primary:   Hemagglutination Inhibition (HI) Antibody Titers   [ Time Frame: At Day 0 and 21 ]

2.  Primary:   Number of Seroconverted Subjects   [ Time Frame: At Day 21 ]

3.  Primary:   Number of Seroprotected Subjects   [ Time Frame: At Day 0 and 21 ]

4.  Primary:   Fold Increase From Baseline in Serum HI Antibody Titer   [ Time Frame: At Day 21 ]

5.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ]

6.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]

7.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]


  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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00718120     History of Changes
Other Study ID Numbers: 110584
Study First Received: July 17, 2008
Results First Received: July 16, 2009
Last Updated: October 8, 2009
Health Authority: Canada: Health Canada