Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01636102
First received: July 5, 2012
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Human Influenza
Intervention: Biological: Trivalent influenza virus vaccine (TIV)

  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
Subjects were enrolled at 1 site in Belgium.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial.

Reporting Groups
  Description
18-60 Y Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
≥61 Y Subjects ≥61 years of age who received one TIV vaccination

Participant Flow:   Overall Study
    18-60 Y     ≥61 Y  
STARTED     63     63  
COMPLETED     63     63  
NOT COMPLETED     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
18-60 Y Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
≥61 Y Subjects ≥61 years of age who received one TIV vaccination
Total Total of all reporting groups

Baseline Measures
    18-60 Y     ≥61 Y     Total  
Number of Participants  
[units: participants]
  63     63     126  
Age  
[units: years]
Mean ± Standard Deviation
  37.9  ± 12.8     69.2  ± 5.7     53.6  ± 18.5  
Gender  
[units: participants]
     
Female     39     26     65  
Male     24     37     61  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV   [ Time Frame: Day 22 ]

2.  Primary:   Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV   [ Time Frame: Day 22 ]

3.  Primary:   Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV   [ Time Frame: Day 1 and 22 ]

4.  Secondary:   Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)   [ Time Frame: From day 1 through day 4 postvaccination ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01636102     History of Changes
Other Study ID Numbers: V71_32S, 2012-000063-24
Study First Received: July 5, 2012
Results First Received: July 11, 2013
Last Updated: December 23, 2013
Health Authority: European Union: European Medicines Agency