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

  Hide Study Locations
Locations
United States, Arizona
301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
Phoenix, Arizona, United States, 85253
United States, Florida
318 Avail Clinical Research, 860 Peachwood Drive
Deland, Florida, United States, 32720
306 Westside Center for Clinical Research, 810 Lane Avenue South
Jacksonville, Florida, United States, 32205
328 Miami Research Associates, 6141 Sunset Drive
Miami, Florida, United States, 33143
United States, Kansas
320 Johnson County Clin-Trials, 15602 College Blvd
Lenexa, Kansas, United States, 66219
316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
Newton, Kansas, United States, 67114
322 Heartland Research Associates Wichita, 1709 S. Rock Road
Wichita, Kansas, United States, 67207
310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
Wichita, Kansas, United States, 67205
United States, Missouri
314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
Saint Louis, Missouri, United States, 63104
330 Mercy Health Research, 12680 Olive Blvd Suite 200
Saint Louis, Missouri, United States, 63141
United States, Nevada
313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
Las Vegas, Nevada, United States, 89130
United States, New York
311 Regional Clinical Research INC, 415 Hooper Road
Endwell, New York, United States, 13760
United States, North Carolina
326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
Raleigh, North Carolina, United States, 27612
332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
303 Prestige Clinical Research, 333 Conover Drive
Franklin, Ohio, United States, 45005
United States, Rhode Island
325 Omega Medical Research, 400 Bald Hill Road
Warwick, Rhode Island, United States, 02886
United States, South Carolina
312 Spartanburg Regional Medical Center, 485 Simuel Road
Spartanburg, South Carolina, United States, 29303
United States, Utah
321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
Jordan, Utah, United States
317 J. Lewis Research Inc., 2295 Foothill Drive
Salt Lake City, Utah, United States, 84109
305 Foothill Family Clinic South, 6360 South 3000 East
Salt Lake City, Utah, United States, 84121
United States, Virginia
323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
Fairfax, Virginia, United States, 22030
Colombia
209, Centro de Investigacion CAFAM
Avenida Carrera 68, Bogota, Colombia
213, Centro de Atencion e Investigacion Medica CAIMED
Carrera 42A, Bogota, Colombia, 1750
206, Centro de Atencion e Investigacion Medica CAIMED
Carrera 42A, Bogota, Colombia, 1750
207, Centro de Investigacion Cafesalud Medicina Prepagada
Cra 14 No Piso Sexto, Bogota, Colombia
Panama
203, Health Research International HRI
Clayton ciudad del Saber Edificio 118, Panama
205, Medical and Research Center Calle 53 Urbanizacion Marbella
Consultorios Royal Center 108, Panama
Philippines
103, De La Salle Health Sciences Institute
DBB B Dasmarinas, Cavite, Philippines, 4114
102, De La Salle Health Sciences Institute
Dbbb Dasmarinas, Cavite, Philippines, 4114
105, Manila Doctors Hospital, 667 United Nations Avenue
Ermita, Manila, Philippines, 1000
106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
Mesa, Manila, Philippines, 1016
104 Jose Reyes Memorial Medical Center
Rizal Avenue Avenida Cruz, Manila, Philippines, 1003
107 Philippine General Hospital
Taft Avenue, Manila, Philippines, 1000
101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
Corporate City Alabang, Muntinlupa, Philippines, 1781
109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
Corporate City Alabang, Muntinlupa, Philippines
108, City Health Office 1 Rosa City
City Health Office 1, Rosa City, Philippines, 4026
110, San Juan de Dios Hospital, 2772 Roxas Blvd
Pasay City, Philippines, 1300
111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
Quezon City, Philippines, 1102
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 21, 2014