Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00956761
First received: August 8, 2009
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: December 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Seasonal Influenza
Intervention: Biological: Seasonal Influenza Vaccine (MF59C.1)

  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
Overall, 63 participants ≥65 years of age were enrolled at 2 sites in Italy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.

Reporting Groups
  Description
FLUAD Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.

Participant Flow:   Overall Study
    FLUAD  
STARTED     63  
COMPLETED     63  
NOT COMPLETED     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 analysis population was defined as all participants who were enrolled.

Reporting Groups
  Description
FLUAD Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.

Baseline Measures
    FLUAD  
Number of Participants  
[units: participants]
  63  
Age  
[units: Years]
Mean (Standard Deviation)
  72.9  (6.0)  
Gender  
[units: Participants]
 
Female     27  
Male     36  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD   [ Time Frame: Day 21 ]

2.  Primary:   Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD   [ Time Frame: day 21 ]

3.  Primary:   Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD   [ Time Frame: day 21 ]

4.  Primary:   Number of Participants Who Reported Solicited Local and Systemic Reactions   [ Time Frame: 0-3 days 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 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: Posting Director
Organization: Novartis Vaccines and Diagnostics S.r.l
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00956761     History of Changes
Other Study ID Numbers: V70_09S
2009-010586-23
Study First Received: August 8, 2009
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: Italy: EMEA