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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01162122
First received: July 13, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

July 13, 2010
December 3, 2012
August 2010
August 2011   (final data collection date for primary outcome measure)
  • Immunologic equivalence of 3 consecutive production lots of MF59-adjuvanted subunit seasonal influenza vaccine, as measured by Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) for each virus strain after a single 0.5mL IM injection [ Time Frame: 21 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI [ Time Frame: 21 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI [ Time Frame: 180 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI [ Time Frame: 365 days post immunization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01162122 on ClinicalTrials.gov Archive Site
  • Antibody response to heterologous antigens as measured by HI [ Time Frame: 21 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI in a subset of subjects with pre-defined chronic disease [ Time Frame: 21 days post immunization ] [ Designated as safety issue: No ]
  • Clinical Effectiveness of MF59-adjuvanted subunit seasonal influenza vaccine compared to non-adjuvanted seasonal influenza vaccine [ Time Frame: Days 23 to 365 ] [ Designated as safety issue: No ]
  • Antibody response to heterologous antigens as measured by HI [ Time Frame: 180 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to heterologous antigens as measured by HI [ Time Frame: 365 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI in a subset of subjects with pre-defined chronic disease [ Time Frame: 180 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI in a subset of subjects with pre-defined chronic disease [ Time Frame: 365 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to heterologous antigens as measured by HI [ Time Frame: 21 days, 180 days, and 365 days post immunization ] [ Designated as safety issue: No ]
  • Antibody response to homologous antigens as measured by HI in a subset of subjects with pre-defined chronic disease [ Time Frame: 21 days, 180 days, and 365 days post immunization ] [ Designated as safety issue: No ]
  • Clinical Effectiveness of MF59-adjuvanted subunit seasonal influenza vaccine compared to non-adjuvanted seasonal influenza vaccine [ Time Frame: Days 23 to 365 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation
    one dose 0.5mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
    Other Name: FLUAD
  • Biological: Non-adjuvanted trivalent subunit influenza vaccine, 2010/2011 formulation
    one 0.5mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
    Other Name: AGRIFLU
  • Experimental: Group 1
    Intervention: Biological: A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation
  • Experimental: Group 2
    Intervention: Biological: A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation
  • Experimental: Group 3
    Intervention: Biological: A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation
  • Experimental: Group 4
    Intervention: Biological: Non-adjuvanted trivalent subunit influenza vaccine, 2010/2011 formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7109
November 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.

Exclusion Criteria:

  • Any suspected impairment of the immune system.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   Panama,   Philippines
 
NCT01162122
V70_27
Not Provided
Novartis
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
December 2012

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