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Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01162122
First received: July 13, 2010
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Biological: Non-adjuvanted trivalent subunit influenza 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 from 4 sites in Columbia, 2 sites in Panama, 11 sites in Philippines, 21 sites in USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five enrolled subjects were not randomized and did not receive study vaccination, hence were discontinued.

Reporting Groups
  Description
aTIV (Pooled) Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Licensed TIV Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Participant Flow:   Overall Study
    aTIV (Pooled)     Licensed TIV  
STARTED     3552     3552  
Vaccinated     3541     3541  
COMPLETED     3361     3356  
NOT COMPLETED     191     196  
Withdrawal by Subject                 52                 43  
Lost to Follow-up                 73                 91  
Adverse Event                 3                 2  
Death                 51                 46  
Protocol Violation                 2                 2  
Inappropriate enrollment                 5                 4  
Administrative reason                 1                 1  
Unable to classify                 3                 7  
Missing primary reason                 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.

Baseline demography is described for safety set population.

A vaccine different from the vaccine assigned at randomization was administered to 7 subjects in each vaccine group. For the safety analysis, these subjects were reassigned to the vaccine group for the vaccine they actually received.


Reporting Groups
  Description
aTIV (Pooled) Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Licensed TIV Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Total Total of all reporting groups

Baseline Measures
    aTIV (Pooled)     Licensed TIV     Total  
Number of Participants  
[units: participants]
  3545     3537     7082  
Age  
[units: years]
Mean ± Standard Deviation
  72.0  ± 5.3     71.8  ± 5.3     71.9  ± 5.3  
Gender  
[units: participants]
     
Female     2272     2342     4614  
Male     1273     1195     2468  



  Outcome Measures
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1.  Primary:   Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV   [ Time Frame: Day 22 post vaccination ]

2.  Primary:   Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS   [ Time Frame: Day 22 post vaccination ]

3.  Primary:   Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS   [ Time Frame: Day 22 post vaccination ]

4.  Primary:   Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)   [ Time Frame: Day 22 post vaccination ]

5.  Primary:   Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS   [ Time Frame: Day 22 post vaccination ]

6.  Primary:   Percentage of Subjects With HI Titers ≥40 Against Homologous Strains   [ Time Frame: Day 22 post vaccination ]

7.  Primary:   Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains   [ Time Frame: Day 22 post vaccination ]

8.  Primary:   Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains   [ Time Frame: Day 22 post vaccination ]

9.  Primary:   Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains   [ Time Frame: Day 22 post vaccination ]

10.  Primary:   Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains   [ Time Frame: Day 22 post vaccination ]

11.  Primary:   Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains   [ Time Frame: Day 22 post vaccination ]

12.  Secondary:   Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS   [ Time Frame: Day 22 post vaccination ]

13.  Secondary:   Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS   [ Time Frame: Day 22 post vaccination ]

14.  Secondary:   Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS   [ Time Frame: Day 22 post vaccination ]

15.  Secondary:   Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS   [ Time Frame: Day 22 postvaccination ]

16.  Secondary:   Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS   [ Time Frame: Day 22 post vaccination ]

17.  Secondary:   Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS   [ Time Frame: Day 22 post vaccination ]

18.  Secondary:   Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS   [ Time Frame: Day 22 postvaccination ]

19.  Secondary:   Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS   [ Time Frame: Day 22 post vaccination ]

20.  Secondary:   Persistence of GMTs Against Homologous and Heterologous Strains   [ Time Frame: Day 181, Day 366 post vaccination ]

21.  Secondary:   Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains   [ Time Frame: Day 181, Day 366 post vaccination ]

22.  Secondary:   Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups   [ Time Frame: Day 22 through Day 366 post vaccination ]

23.  Secondary:   Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups   [ Time Frame: Day 1 through Day 366 post vaccination ]

24.  Secondary:   Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups   [ Time Frame: Day 1 through Day 366 post vaccination ]

25.  Secondary:   All Cause Mortality Rate, Across Vaccine Groups   [ Time Frame: Day 1 through Day 366 post vaccination ]

26.  Secondary:   Number of Subjects Reporting Solicited Adverse Events Following Vaccination   [ Time Frame: Day 1 through Day 7 post vaccination ]


  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 Other disclosure agreement that restricts the right of the PI 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 by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01162122     History of Changes
Other Study ID Numbers: V70_27
Study First Received: July 13, 2010
Results First Received: January 28, 2014
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration