A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01113580
First received: April 26, 2010
Last updated: June 13, 2012
Last verified: June 2012
Results First Received: June 13, 2012  
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: CSL's 2010/2011 Formulation of Enzira® Vaccine

  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
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Reporting Groups
  Description
Adults Healthy volunteers aged 18 to 59 years
Older Adults Healthy volunteers aged 60 years or older

Participant Flow:   Overall Study
    Adults     Older Adults  
STARTED     60     60  
COMPLETED     59     60  
NOT COMPLETED     1     0  
Protocol Violation                 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.
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Reporting Groups
  Description
Adults Healthy volunteers aged 18 to 59 years
Older Adults Healthy volunteers aged 60 years or older
Total Total of all reporting groups

Baseline Measures
    Adults     Older Adults     Total  
Number of Participants  
[units: participants]
  60     60     120  
Age, Customized  
[units: participants]
     
< 18 years     0     0     0  
18 to 59 years     60     0     60  
>= 60 years     0     60     60  
Gender  
[units: participants]
     
Female     29     24     53  
Male     31     36     67  



  Outcome Measures
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1.  Primary:   The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.   [ Time Frame: Approximately 21 days after vaccination ]

2.  Primary:   The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.   [ Time Frame: Approximately 21 days after vaccination ]

3.  Primary:   The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.   [ Time Frame: Approximately 21 days after vaccination ]

4.  Secondary:   Frequency of Any Solicited Adverse Events (AEs)   [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ]

5.  Secondary:   Frequency and Intensity of Any Unsolicited Adverse Events   [ Time Frame: After vaccination until the end of the study; approximately 21 days ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
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Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Limited
phone: Use email contact
e-mail: csl.clinicaltrials@csl.com.au


No publications provided


Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01113580     History of Changes
Other Study ID Numbers: CSLCT-ASU-10-66, 2010-019532-12
Study First Received: April 26, 2010
Results First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency