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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:
Novartis
ClinicalTrials.gov Identifier:
NCT00956761
First received: August 8, 2009
Last updated: August 10, 2009
Last verified: August 2009
History of Changes

August 8, 2009
August 10, 2009
June 2009
July 2009   (final data collection date for primary outcome measure)
To evaluate the antibody response to each flu vaccine antigen, as measured by SRH at 21 days post-immunization in elderly subjects in compliance with the requirements of the EU recommendations for clin. trials related to yearly licensing of flu vaccines [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00956761 on ClinicalTrials.gov Archive Site
To evaluate the safety of a IM injection of an MF59 -adjuvanted seasonal flu vaccine in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2009-2010, When Administered to Elderly Subjects

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Seasonal Influenza
Biological: Seasonal Influenza Vaccine (MF59C.1)
1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010
Experimental: 1
Intervention: Biological: Seasonal Influenza Vaccine (MF59C.1)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects of 65 years of age or older
  • Mentally competent
  • Willing and able to give written informed consent prior to study entry
  • Able to comply with all the study requirements
  • In general good health

Exclusion Criteria:

  • Any serious chronic or acute disease disease
  • History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
  • A proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate)
  • Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
  • Known or suspected history of drug or alcohol abuse
  • Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
  • Within the past 12 months, they have received more than one injection of influenza vaccine
  • Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00956761
V70_09S, 2009-010586-23
Not Provided
Novartis, Novartis Vaccines
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP