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
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: A trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, 2010/2011 formulation
Biological: Non-adjuvanted trivalent subunit influenza vaccine, 2010/2011 formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7109
Study Start Date: August 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 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
Experimental: Group 2 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
Experimental: Group 3 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
Experimental: Group 4 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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162122

  Show 38 Study Locations
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01162122     History of Changes
Other Study ID Numbers: V70_27
Study First Received: July 13, 2010
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Elderly
Influenza
Immunogenicity
Safety
Adjuvant
Adjuvanted
Adjuvants
Vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Formaldehyde
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014