A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01144299
First received: June 10, 2010
Last updated: October 27, 2011
Last verified: October 2011
Results First Received: October 1, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Seasonal Influenza
Intervention: Biological: Fluarix™/Influsplit SSW®

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Fluarix Adult Group Subjects aged 18 to 60 years received one dose of Fluarix™.
Fluarix Elderly Group Subjects aged > 60 years received one dose of Fluarix™.

Participant Flow:   Overall Study
    Fluarix Adult Group     Fluarix Elderly Group  
STARTED     60     54  
COMPLETED     58     54  
NOT COMPLETED     2     0  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
  Hide 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
Fluarix Adult Group Subjects aged 18 to 60 years received one dose of Fluarix™.
Fluarix Elderly Group Subjects aged > 60 years received one dose of Fluarix™.
Total Total of all reporting groups

Baseline Measures
    Fluarix Adult Group     Fluarix Elderly Group     Total  
Number of Participants  
[units: participants]
  60     54     114  
Age  
[units: Years]
Mean ± Standard Deviation
  37.1  ± 13.10     68.6  ± 5.08     52.1  ± 18.83  
Gender  
[units: Subjects]
     
Female     32     26     58  
Male     28     28     56  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hemagglutination Inhibition (HI) Antibody Titer   [ Time Frame: Day 0 and Day 21 ]

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

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

4.  Primary:   Seroconversion Factor   [ Time Frame: Day 21 ]

5.  Primary:   Seroprotection Power   [ Time Frame: Day 21 ]

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

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

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

9.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: During the entire study period (From Day 0 up to Day 21) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide 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.


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.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01144299     History of Changes
Other Study ID Numbers: 114292
Study First Received: June 10, 2010
Results First Received: October 1, 2010
Last Updated: October 27, 2011
Health Authority: Germany : German Federal Ministry of Health