search
Back to results

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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Elderly, Influenza, Immunogenicity, Safety, Adjuvant, Adjuvanted, Adjuvants, Vaccines

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
  • 318 Avail Clinical Research, 860 Peachwood Drive
  • 306 Westside Center for Clinical Research, 810 Lane Avenue South
  • 328 Miami Research Associates, 6141 Sunset Drive
  • 320 Johnson County Clin-Trials, 15602 College Blvd
  • 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
  • 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
  • 322 Heartland Research Associates Wichita, 1709 S. Rock Road
  • 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
  • 330 Mercy Health Research, 12680 Olive Blvd Suite 200
  • 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
  • 311 Regional Clinical Research INC, 415 Hooper Road
  • 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
  • 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
  • 303 Prestige Clinical Research, 333 Conover Drive
  • 325 Omega Medical Research, 400 Bald Hill Road
  • 312 Spartanburg Regional Medical Center, 485 Simuel Road
  • 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
  • 317 J. Lewis Research Inc., 2295 Foothill Drive
  • 305 Foothill Family Clinic South, 6360 South 3000 East
  • 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
  • 209, Centro de Investigacion CAFAM
  • 206, Centro de Atencion e Investigacion Medica CAIMED
  • 213, Centro de Atencion e Investigacion Medica CAIMED
  • 207, Centro de Investigacion Cafesalud Medicina Prepagada
  • 203, Health Research International HRI
  • 205, Medical and Research Center Calle 53 Urbanizacion Marbella
  • 103, De La Salle Health Sciences Institute
  • 102, De La Salle Health Sciences Institute
  • 105, Manila Doctors Hospital, 667 United Nations Avenue
  • 106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
  • 104 Jose Reyes Memorial Medical Center
  • 107 Philippine General Hospital
  • 101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
  • 109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
  • 108, City Health Office 1 Rosa City
  • 110, San Juan de Dios Hospital, 2772 Roxas Blvd
  • 111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

aTIV

Licensed TIV

Arm Description

Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).

Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Outcomes

Primary Outcome Measures

Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.

Secondary Outcome Measures

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
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
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Persistence of GMTs Against Homologous and Heterologous Strains
The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
All Cause Mortality Rate, Across Vaccine Groups
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.

Full Information

First Posted
July 13, 2010
Last Updated
June 16, 2014
Sponsor
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT01162122
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Elderly, Influenza, Immunogenicity, Safety, Adjuvant, Adjuvanted, Adjuvants, Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aTIV
Arm Type
Experimental
Arm Description
Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
Arm Title
Licensed TIV
Arm Type
Experimental
Arm Description
Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
Intervention Type
Biological
Intervention Name(s)
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Other Intervention Name(s)
Fluad
Intervention Description
one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
Intervention Type
Biological
Intervention Name(s)
Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Other Intervention Name(s)
Agriflu
Intervention Description
one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
Primary Outcome Measure Information:
Title
Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Description
Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS
Description
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS
Description
The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)
Description
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS
Description
The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains. Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Title
Percentage of Subjects With HI Titers ≥40 Against Homologous Strains
Description
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame
Day 22 post vaccination
Title
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains
Description
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Title
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains
Description
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame
Day 22 post vaccination
Title
Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains
Description
The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame
Day 22 post vaccination
Title
Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains
Description
The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.
Time Frame
Day 22 post vaccination
Title
Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains
Description
The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Secondary Outcome Measure Information:
Title
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Description
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame
Day 22 post vaccination
Title
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
Description
The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
Description
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.
Time Frame
Day 22 post vaccination
Title
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
Description
The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 postvaccination
Title
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
Description
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .
Time Frame
Day 22 post vaccination
Title
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
Description
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.
Time Frame
Day 22 post vaccination
Title
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
Description
The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 postvaccination
Title
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
Description
The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 22 post vaccination
Title
Persistence of GMTs Against Homologous and Heterologous Strains
Description
The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.
Time Frame
Day 181, Day 366 post vaccination
Title
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
Description
The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10.
Time Frame
Day 181, Day 366 post vaccination
Title
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Description
The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.
Time Frame
Day 22 through Day 366 post vaccination
Title
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
Description
The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.
Time Frame
Day 1 through Day 366 post vaccination
Title
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
Description
The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.
Time Frame
Day 1 through Day 366 post vaccination
Title
All Cause Mortality Rate, Across Vaccine Groups
Description
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Time Frame
Day 1 through Day 366 post vaccination
Title
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Description
The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.
Time Frame
Day 1 through Day 7 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study. Known or suspected impairment/alteration of immune function. Individuals with a known bleeding diathesis. History of Guillain-Barré syndrome. 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). 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. 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. Individuals who had received vaccination against seasonal influenza in the previous 6 months. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination. Individuals with history of substance or alcohol abuse within the past 2 years. Individuals providing consent who did not consent to the retention of their serum samples after study completion. 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. Subjects from whom blood could not be drawn at visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
318 Avail Clinical Research, 860 Peachwood Drive
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
306 Westside Center for Clinical Research, 810 Lane Avenue South
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
328 Miami Research Associates, 6141 Sunset Drive
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
320 Johnson County Clin-Trials, 15602 College Blvd
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
322 Heartland Research Associates Wichita, 1709 S. Rock Road
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
330 Mercy Health Research, 12680 Olive Blvd Suite 200
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
Facility Name
311 Regional Clinical Research INC, 415 Hooper Road
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
303 Prestige Clinical Research, 333 Conover Drive
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
325 Omega Medical Research, 400 Bald Hill Road
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
312 Spartanburg Regional Medical Center, 485 Simuel Road
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
City
Jordan
State/Province
Utah
Country
United States
Facility Name
317 J. Lewis Research Inc., 2295 Foothill Drive
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
305 Foothill Family Clinic South, 6360 South 3000 East
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
209, Centro de Investigacion CAFAM
City
Avenida Carrera 68
State/Province
Bogota
Country
Colombia
Facility Name
206, Centro de Atencion e Investigacion Medica CAIMED
City
Carrera 42A
State/Province
Bogota
ZIP/Postal Code
1750
Country
Colombia
Facility Name
213, Centro de Atencion e Investigacion Medica CAIMED
City
Carrera 42A
State/Province
Bogota
ZIP/Postal Code
1750
Country
Colombia
Facility Name
207, Centro de Investigacion Cafesalud Medicina Prepagada
City
Cra 14 No Piso Sexto
State/Province
Bogota
Country
Colombia
Facility Name
203, Health Research International HRI
City
Clayton ciudad del Saber Edificio 118
Country
Panama
Facility Name
205, Medical and Research Center Calle 53 Urbanizacion Marbella
City
Consultorios Royal Center 108
Country
Panama
Facility Name
103, De La Salle Health Sciences Institute
City
DBB B Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
102, De La Salle Health Sciences Institute
City
Dbbb Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
105, Manila Doctors Hospital, 667 United Nations Avenue
City
Ermita
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
City
Mesa
State/Province
Manila
ZIP/Postal Code
1016
Country
Philippines
Facility Name
104 Jose Reyes Memorial Medical Center
City
Rizal Avenue Avenida Cruz
State/Province
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
107 Philippine General Hospital
City
Taft Avenue
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
City
Corporate City Alabang
State/Province
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
City
Corporate City Alabang
State/Province
Muntinlupa
Country
Philippines
Facility Name
108, City Health Office 1 Rosa City
City
City Health Office 1
State/Province
Rosa City
ZIP/Postal Code
4026
Country
Philippines
Facility Name
110, San Juan de Dios Hospital, 2772 Roxas Blvd
City
Pasay City
ZIP/Postal Code
1300
Country
Philippines
Facility Name
111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
25045825
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs