Clinical trial NCT01162122: Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Elderly
Influenza
Immunogenicity
Safety
Adjuvant
Adjuvanted
Adjuvants
Vaccines
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-14
Enrollment: 7109
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.

Exclusion Criteria:

1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
3. Known or suspected impairment/alteration of immune function.
4. Individuals with a known bleeding diathesis.
5. History of Guillain-Barré syndrome.
6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
7. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
11. Individuals with history of substance or alcohol abuse within the past 2 years.
12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
14. Subjects from whom blood could not be drawn at visit 1.

Primary outcomes:
measure: Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
timeFrame: Day 22 post vaccination
measure: Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
timeFrame: Day 22 post vaccination
measure: Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
timeFrame: Day 22 post vaccination
measure: Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
timeFrame: Day 22 post vaccination
measure: Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
timeFrame: Day 22 post vaccination
measure: Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
timeFrame: Day 22 post vaccination
measure: Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
timeFrame: Day 22 post vaccination
Secondary outcomes:
measure: Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
timeFrame: Day 22 post vaccination
measure: Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
timeFrame: Day 22 post vaccination
measure: Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
timeFrame: Day 22 postvaccination
measure: Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
timeFrame: Day 22 post vaccination
measure: Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
timeFrame: Day 22 post vaccination
measure: Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
timeFrame: Day 22 postvaccination
measure: Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
timeFrame: Day 22 post vaccination
measure: Persistence of GMTs Against Homologous and Heterologous Strains
timeFrame: Day 181, Day 366 post vaccination
measure: Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
timeFrame: Day 181, Day 366 post vaccination
measure: Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
timeFrame: Day 22 through Day 366 post vaccination
measure: Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
timeFrame: Day 1 through Day 366 post vaccination
measure: Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
timeFrame: Day 1 through Day 366 post vaccination
measure: All Cause Mortality Rate, Across Vaccine Groups
timeFrame: Day 1 through Day 366 post vaccination
measure: Number of Subjects Reporting Solicited Adverse Events Following Vaccination
timeFrame: Day 1 through Day 7 post vaccination
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
state: Arizona
city: Deland
country: United States
facility: 318 Avail Clinical Research, 860 Peachwood Drive
state: Florida
city: Jacksonville
country: United States
facility: 306 Westside Center for Clinical Research, 810 Lane Avenue South
state: Florida
city: Miami
country: United States
facility: 328 Miami Research Associates, 6141 Sunset Drive
state: Florida
city: Lenexa
country: United States
facility: 320 Johnson County Clin-Trials, 15602 College Blvd
state: Kansas
city: Newton
country: United States
facility: 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
state: Kansas
city: Wichita
country: United States
facility: 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
state: Kansas
city: Wichita
country: United States
facility: 322 Heartland Research Associates Wichita, 1709 S. Rock Road
state: Kansas
city: Saint Louis
country: United States
facility: 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
state: Missouri
city: Saint Louis
country: United States
facility: 330 Mercy Health Research, 12680 Olive Blvd Suite 200
state: Missouri
city: Las Vegas
country: United States
facility: 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
state: Nevada
city: Endwell
country: United States
facility: 311 Regional Clinical Research INC, 415 Hooper Road
state: New York
city: Raleigh
country: United States
facility: 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
state: North Carolina
city: Winston-Salem
country: United States
facility: 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
state: North Carolina
city: Franklin
country: United States
facility: 303 Prestige Clinical Research, 333 Conover Drive
state: Ohio
city: Warwick
country: United States
facility: 325 Omega Medical Research, 400 Bald Hill Road
state: Rhode Island
city: Spartanburg
country: United States
facility: 312 Spartanburg Regional Medical Center, 485 Simuel Road
state: South Carolina
city: Jordan
country: United States
facility: 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
state: Utah
city: Salt Lake City
country: United States
facility: 317 J. Lewis Research Inc., 2295 Foothill Drive
state: Utah
city: Salt Lake City
country: United States
facility: 305 Foothill Family Clinic South, 6360 South 3000 East
state: Utah
city: Fairfax
country: United States
facility: 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
state: Virginia
city: Avenida Carrera 68
country: Colombia
facility: 209, Centro de Investigacion CAFAM
state: Bogota
city: Carrera 42A
country: Colombia
facility: 206, Centro de Atencion e Investigacion Medica CAIMED
state: Bogota
city: Carrera 42A
country: Colombia
facility: 213, Centro de Atencion e Investigacion Medica CAIMED
state: Bogota
city: Cra 14 No Piso Sexto
country: Colombia
facility: 207, Centro de Investigacion Cafesalud Medicina Prepagada
state: Bogota
city: Clayton ciudad del Saber Edificio 118
country: Panama
facility: 203, Health Research International HRI
city: Consultorios Royal Center 108
country: Panama
facility: 205, Medical and Research Center Calle 53 Urbanizacion Marbella
city: DBB B Dasmarinas
country: Philippines
facility: 103, De La Salle Health Sciences Institute
state: Cavite
city: Dbbb Dasmarinas
country: Philippines
facility: 102, De La Salle Health Sciences Institute
state: Cavite
city: Ermita
country: Philippines
facility: 105, Manila Doctors Hospital, 667 United Nations Avenue
state: Manila
city: Mesa
country: Philippines
facility: 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
state: Manila
city: Rizal Avenue Avenida Cruz
country: Philippines
facility: 104 Jose Reyes Memorial Medical Center
state: Manila
city: Taft Avenue
country: Philippines
facility: 107 Philippine General Hospital
state: Manila
city: Corporate City Alabang
country: Philippines
facility: 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
state: Muntinlupa
city: Corporate City Alabang
country: Philippines
facility: 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
state: Muntinlupa
city: City Health Office 1
country: Philippines
facility: 108, City Health Office 1 Rosa City
state: Rosa City
city: Pasay City
country: Philippines
facility: 110, San Juan de Dios Hospital, 2772 Roxas Blvd
city: Quezon City
country: Philippines
facility: 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.