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A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303510
First Posted: February 24, 2011
Last Update Posted: September 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Crucell Holland BV
Results First Submitted: October 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 FSFV: 09-Jul-2008 LSLV: 30-Jul-2008

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

Participant Flow:   Overall Study
    Group A   Group B
STARTED   55   56 
COMPLETED   54   56 
NOT COMPLETED   1   0 
Lost to Follow-up                1                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
Group A Adults from 18 to 60 years old inclusive
Group B Elderly subjects aged over 60 years
Total Total of all reporting groups

Baseline Measures
   Group A   Group B   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   56   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (13.0)   69.3  (5.2)   54.4  (18.0) 
Gender 
[Units: Participants]
     
Female   26   25   51 
Male   29   31   60 


  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: Incidence of Solicited Local Adverse Events   [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]

5.  Secondary:   Incidence of 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



Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01303510     History of Changes
Other Study ID Numbers: INF-V-A002
First Submitted: February 23, 2011
First Posted: February 24, 2011
Results First Submitted: October 10, 2011
Results First Posted: December 19, 2011
Last Update Posted: September 9, 2013