Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM

This study has been terminated.
(The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160237
First received: July 8, 2010
Last updated: February 21, 2012
Last verified: February 2012
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza Infection
Interventions: Biological: Pandemrix™
Biological: Fluarix™/ Influsplit SSW® 2010/2011

  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
Pandemrix Group Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Fluarix Group Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.

Participant Flow:   Overall Study
    Pandemrix Group     Fluarix Group     Control Group  
STARTED     4     3     0  
COMPLETED     4     3     0  
NOT COMPLETED     0     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
Pandemrix Group Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Fluarix Group Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Total Total of all reporting groups

Baseline Measures
    Pandemrix Group     Fluarix Group     Control Group     Total  
Number of Participants  
[units: participants]
  4     3     0     7  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 9.50     55.3  ± 18.80         58.7  ± 13.16  
Gender  
[units: subjects]
       
Female     3     2         5  
Male     1     1         2  



  Outcome Measures
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1.  Primary:   Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years   [ Time Frame: 21 days after vaccination ]

2.  Secondary:   Solicited Local and General Symptoms   [ Time Frame: During 7 days (Day 0 - Day 6) after vaccination ]

3.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: During 31 days (Day 0 - Day 30) after vaccination ]

4.  Secondary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: During the whole study period (Day 0 - Day 182) ]

5.  Secondary:   Potential Immune Mediated Diseases   [ Time Frame: During the whole study period (Day 0 - Day 182) ]

6.  Secondary:   Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years   [ Time Frame: At Days 0, 7 and 182 ]


  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
Only 7 subjects were enrolled in either the Pandemrix Group or the Fluarix Group and none in the Control Group since the study was terminated prematurely. Therefore most outcome measures (except unsolicited AEs and SAEs) were not analysed.


  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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01160237     History of Changes
Other Study ID Numbers: 114454
Study First Received: July 8, 2010
Results First Received: February 21, 2012
Last Updated: February 21, 2012
Health Authority: Germany: Paul-Ehrlich-Institut