Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00560066
First received: November 16, 2007
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: November 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Seasonal Influenza
Vaccine
Interventions: Biological: Cell-derived influenza vaccine
Biological: Egg-derived influenza 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
Subjects were enrolled at 17 centres in Germany.

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

Reporting Groups
  Description
Egg-derived Vaccine (TIV) Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
Cell Culture-derived Vaccine (cTIV) Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine

Participant Flow:   Overall Study
    Egg-derived Vaccine (TIV)     Cell Culture-derived Vaccine (cTIV)  
STARTED     396     1002  
COMPLETED     390     980  
NOT COMPLETED     6     22  
Death                 2                 1  
Withdrawal by Subject                 0                 3  
Lost to Follow-up                 4                 10  
Protocol Violation                 0                 1  
Administrative reason                 0                 5  
Missing primary reason                 0                 2  



  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
Egg-derived Vaccine (TIV) Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
Cell Culture-derived Vaccine (cTIV) Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
Total Total of all reporting groups

Baseline Measures
    Egg-derived Vaccine (TIV)     Cell Culture-derived Vaccine (cTIV)     Total  
Number of Participants  
[units: participants]
  396     1002     1398  
Age  
[units: years]
Mean ± Standard Deviation
  47.6  ± 17.3     48.7  ± 16.3     48.3  ± 16.6  
Gender  
[units: participants]
     
Female     206     533     739  
Male     190     469     659  



  Outcome Measures
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1.  Primary:   Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV   [ Time Frame: From day 1 upto and including day 7 postvaccination ]

2.  Secondary:   Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV   [ Time Frame: From day 1 through day 7 postvaccination ]

3.  Secondary:   Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV   [ Time Frame: From day 1 through day 7 postvaccination ]

4.  Secondary:   Percentages Of Subjects With Underlying Medical Conditions Who Achieved HI Titer ≥40 After One Vaccination of TIV or cTIV   [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ]

5.  Secondary:   Percentages Of Subjects With Underlying Medical Conditions Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV   [ Time Frame: Three weeks after vaccination (day 22) ]

6.  Secondary:   Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV   [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ]

7.  Secondary:   Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV   [ Time Frame: Three weeks after vaccination (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
Because cTIV was not available, the second part of the study was not performed. In addition, as deviations from protocol procedures and GCP were identified at some sites, data collected for this study were not used to support licensure of cTIV.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: NCT00560066     History of Changes
Other Study ID Numbers: V58P14, 2007-002872-32
Study First Received: November 16, 2007
Results First Received: November 21, 2012
Last Updated: April 17, 2013
Health Authority: Germany: Paul-Ehrlich-Institute