A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01306253
First received: February 28, 2011
Last updated: August 29, 2013
Last verified: August 2013
Results First Received: December 14, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Influenza
Intervention: Biological: Inflexal V

  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
Participants were recruited at one center in Switzerland First subject first visit (FSFV): 05-Jun-2009 Last subject last visit (LSLV): 30-Jun-2009

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
Adults Adults from 18 to 60 years old inclusive
Elderly Elderly subjects aged over 60 years

Participant Flow:   Overall Study
    Adults     Elderly  
STARTED     57     57  
COMPLETED     56     56  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 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
Adults Adults from 18 to 60 years old inclusive
Elderly Elderly subjects aged over 60 years
Total Total of all reporting groups

Baseline Measures
    Adults     Elderly     Total  
Number of Participants  
[units: participants]
  57     57     114  
Age  
[units: years]
Mean ± Standard Deviation
  42.3  ± 12.3     68.5  ± 5.8     55.4  ± 16.3  
Gender  
[units: participants]
     
Female     31     30     61  
Male     26     27     53  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Seroconversion   [ Time Frame: Day 22 ± 2 days ]

2.  Primary:   Seroprotection   [ Time Frame: Day 22 ± 2 days ]

3.  Primary:   Fold Increase in Geometric Mean Titer (GMT)   [ Time Frame: Day 22/Day 1 ]

4.  Secondary:   Safety: Numbers of Subjects Reporting Solicited Local Adverse Events   [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]

5.  Secondary:   Numbers of Subjects Reporting Solicited Systemic Adverse Events   [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]


  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: Medical Affairs Director
Organization: Crucell Switzerland AG
phone: +41(0)319806111
e-mail: info@crucell.com


No publications provided


Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01306253     History of Changes
Other Study ID Numbers: INF-V-A003
Study First Received: February 28, 2011
Results First Received: December 14, 2011
Last Updated: August 29, 2013
Health Authority: Switzerland: Swissmedic