InfluenzaPhase 3NCT01162122

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

A Phase 3 study testing MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) and Non-adjuvanted trivalent subunit influenza vaccine (TIV) in people with Influenza, run by Novartis Vaccines at 38 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV) and Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7,109 participants
Where: 38 sitesin 4 countries
Study dates: Aug 2010to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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).

Show all 14Show fewer

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.

Trial locations and contacts

38 sites in 4 countries.

Country

City, postcode or hospital

38 sites in 4 countries

United States21 sites

318 Avail Clinical Research, 860 Peachwood Drive
DeLand, Florida, 32720
311 Regional Clinical Research INC, 415 Hooper Road
Endwell, New York, 13760
323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500
Fairfax, Virginia, 22030
303 Prestige Clinical Research, 333 Conover Drive
Franklin, Ohio, 45005
306 Westside Center for Clinical Research, 810 Lane Avenue South
Jacksonville, Florida, 32205
321 Jordan River Family Medicine, 1868 West 9800 South Ste 100
Jordan, Utah
313 Clinical Research Center of Nevada, 7425 W Azure Suite 150
Las Vegas, Nevada, 89130
320 Johnson County Clin-Trials, 15602 College Blvd
Lenexa, Kansas, 66219
328 Miami Research Associates, 6141 Sunset Drive
Miami, Florida, 33143
316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr
Newton, Kansas, 67114
301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
Phoenix, Arizona, 85253
326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104
Raleigh, North Carolina, 27612
317 J. Lewis Research Inc., 2295 Foothill Drive
Salt Lake City, Utah, 84109
305 Foothill Family Clinic South, 6360 South 3000 East
Salt Lake City, Utah, 84121
312 Spartanburg Regional Medical Center, 485 Simuel Road
Spartanburg, South Carolina, 29303
314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827
St Louis, Missouri, 63104
330 Mercy Health Research, 12680 Olive Blvd Suite 200
St Louis, Missouri, 63141
325 Omega Medical Research, 400 Bald Hill Road
Warwick, Rhode Island, 02886
310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600
Wichita, Kansas, 67205
322 Heartland Research Associates Wichita, 1709 S. Rock Road
Wichita, Kansas, 67207
332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306
Winston-Salem, North Carolina, 27103

Other trials in United States

Philippines11 sites

108, City Health Office 1 Rosa City
City Health Office 1, Rosa City, 4026
101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest
Corporate City Alabang, Muntinlupa, 1781
109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST
Corporate City Alabang, Muntinlupa
103, De La Salle Health Sciences Institute
DBB B Dasmarinas, Cavite, 4114
102, De La Salle Health Sciences Institute
Dbbb Dasmarinas, Cavite, 4114
105, Manila Doctors Hospital, 667 United Nations Avenue
Ermita, Manila, 1000
106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.
Mesa, Manila, 1016
110, San Juan de Dios Hospital, 2772 Roxas Blvd
Pasay, 1300
111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard
Quezon City, 1102
104 Jose Reyes Memorial Medical Center
Rizal Avenue Avenida Cruz, Manila, 1003
107 Philippine General Hospital
Taft Avenue, Manila, 1000

Other trials in Philippines

Colombia4 sites

209, Centro de Investigacion CAFAM
Avenida Carrera 68, Bogota D.C.
206, Centro de Atencion e Investigacion Medica CAIMED
Carrera 42A, Bogota D.C., 1750
213, Centro de Atencion e Investigacion Medica CAIMED
Carrera 42A, Bogota D.C., 1750
207, Centro de Investigacion Cafesalud Medicina Prepagada
Cra 14 No Piso Sexto, Bogota D.C.

Other trials in Colombia

Panama2 sites

203, Health Research International HRI
Clayton Ciudad Del Saber Edificio 118, Provincia de Panamá
205, Medical and Research Center Calle 53 Urbanizacion Marbella
Consultorios Royal Center 108, Provincia de Panamá

Other trials in Panama

About this study

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

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.

Conditions: Influenza
Being tested: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV), Non-adjuvanted trivalent subunit influenza vaccine (TIV)
Keywords: Elderly, Influenza, Immunogenicity, Safety, Adjuvant, Adjuvanted, Adjuvants, Vaccines
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)Biological
Also called Fluad
one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
Non-adjuvanted trivalent subunit influenza vaccine (TIV)Biological
Also called Agriflu
one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Study groups in NCT01162122
Study group	Role	What they receive
aTIV	Experimental	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). Receives: Biological: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)
Licensed TIV	Experimental	Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV). Receives: Biological: Non-adjuvanted trivalent subunit influenza vaccine (TIV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination

Secondary outcomes (15)

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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 22 postvaccination
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 .
Measured: Day 22 post 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.
Measured: Day 22 post 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.
Measured: Day 22 postvaccination
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.
Measured: Day 22 post vaccination
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.
Measured: Day 181, Day 366 post vaccination
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.
Measured: Day 181, Day 366 post vaccination
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.
Measured: Day 22 through Day 366 post vaccination
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.
Measured: Day 1 through Day 366 post vaccination
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.
Measured: Day 1 through Day 366 post vaccination
All Cause Mortality Rate, Across Vaccine Groups
The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.
Measured: Day 1 through Day 366 post vaccination
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.
Measured: Day 1 through Day 7 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Nov 2011

First posted14 Jul 2010 (estimated)
Study startAug 2010
Primary completionAug 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 7,109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01162122
Sponsor's protocol ID: V70_27
Status last verified: Jun 2014
First submitted: 13 Jul 2010
Last updated: 26 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25045825

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01162122
Acronym / sponsor ID: V70_27
Conditions: Influenza
Keywords: Elderly, Influenza, Immunogenicity, Safety, Adjuvant, Adjuvanted, Adjuvants, Vaccines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 7,109 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Aug 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 14 Jul 2010 (estimated)
Results: Posted 12 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
aTIV	Experimental	Biological: MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)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).
Licensed TIV	Experimental	Biological: Non-adjuvanted trivalent subunit influenza vaccine (TIV)Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)Also: Fluadone dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm	Biological	aTIV
Non-adjuvanted trivalent subunit influenza vaccine (TIV)Also: Agrifluone 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm	Biological	Licensed TIV

Primary outcome

Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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)
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
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.

15 secondary outcomes

Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS
Time frame: Day 22 post vaccination
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
Time frame: Day 22 post vaccination
Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS
Time frame: Day 22 post vaccination
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
Time frame: Day 22 postvaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS
Time frame: Day 22 post vaccination
Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS
Time frame: Day 22 post vaccination
Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS
Time frame: Day 22 postvaccination
Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS
Time frame: Day 22 post vaccination
Persistence of GMTs Against Homologous and Heterologous Strains
Time frame: Day 181, Day 366 post vaccination
Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains
Time frame: Day 181, Day 366 post vaccination
Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups
Time frame: Day 22 through Day 366 post vaccination
Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups
Time frame: Day 1 through Day 366 post vaccination
Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups
Time frame: Day 1 through Day 366 post vaccination
All Cause Mortality Rate, Across Vaccine Groups
Time frame: Day 1 through Day 366 post vaccination
Number of Subjects Reporting Solicited Adverse Events Following Vaccination
Time frame: Day 1 through Day 7 post vaccination

Results and safety

Results posted to the registry on 12 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aTIV (Pooled)	3,552	3,361
Licensed TIV	3,552	3,356

Primary outcome: Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV

Time frame: Day 22 post vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	aTIV_Lot 1 n = 1073	aTIV_Lot 2 n = 1078	aTIV_Lot 3 n = 1076
H1N1 strain (N=1072,1078,1075)	209 (189 to 231)	187 (170 to 207)	199 (180 to 220)
H3N2 strain (N=1072,1078,1075)	548 (502 to 598)	542 (498 to 591)	556 (510 to 606)
B strain	56 (51 to 61)	56 (51 to 61)	58 (53 to 64)

aTIV_Lot 1 vs aTIV_Lot 2: GMT ratio (H1N1 strain): 1.12 (95% CI 1 to 1.24)
aTIV_Lot 1 vs aTIV_Lot 3: GMT ratio (H1N1 strain): 1.05 (95% CI 0.95 to 1.17)
aTIV_Lot 2 vs aTIV_Lot 3: GMT ratio (H1N1 strain): 0.94 (95% CI 0.85 to 1.05)

Population analysed: Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.

Primary outcome: Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS

Time frame: Day 22 post vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	aTIV (Pooled) n = 3227	Licensed TIV n = 3259
H1N1 strain (N=3225,3257)	198 (185 to 211)	141 (132 to 150)
H3N2 strain (N=3225,3256)	544 (513 to 575)	337 (319 to 357)
B strain	55 (52 to 58)	48 (46 to 51)

aTIV (Pooled) vs Licensed TIV: GMT ratio (H1N1 strain): 1.4 (95% CI 1.32 to 1.49)
aTIV (Pooled) vs Licensed TIV: GMT ratio (H3N2 strain): 1.61 (95% CI 1.52 to 1.7)
aTIV (Pooled) vs Licensed TIV: GMT ratio (B strain): 1.15 (95% CI 1.08 to 1.21)

Population analysed: Analysis was done on PPS.

Primary outcome: Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS

Time frame: Day 22 post vaccination. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	aTIV (Pooled) n = 3227	Licensed TIV n = 3259
H1N1 strain (N=3225,3257)	77.4 (75.9 to 78.9)	67.6 (65.9 to 69.2)
H3N2 strain (N=3225,3256)	74.0 (72.4 to 75.5)	60.7 (59.0 to 62.3)
B strain	47.0 (45.2 to 48.7)	41.2 (39.5 to 43.0)

aTIV (Pooled) vs Licensed TIV: Group difference (H1N1 strain): 9.2 (95% CI 7.1 to 11.3)
aTIV (Pooled) vs Licensed TIV: Group difference (H3N2 strain): 12.7 (95% CI 10.5 to 14.9)
aTIV (Pooled) vs Licensed TIV: Group difference (B strain): 5.2 (95% CI 3.0 to 7.4)

Population analysed: Analysis was done on PPS.

Primary outcome: Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)

Time frame: Day 22 post vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	aTIV (Pooled) n = 3479	Licensed TIV n = 3482
H1N1 strain (N=3477,3480)	196 (184 to 208)	142 (134 to 151)
H3N2 strain (N=3477,3479)	534 (506 to 563)	334 (317 to 353)
B strain	54 (51 to 57)	48 (45 to 50)

aTIV (Pooled) vs Licensed TIV: GMT ratio (H1N1 strain): 1.37 (95% CI 1.29 to 1.46)
aTIV (Pooled) vs Licensed TIV: GMT ratio (H3N2 strain): 1.60 (95% CI 1.51 to 1.68)
aTIV (Pooled) vs Licensed TIV: GMT ratio (B strain): 1.14 (95% CI 1.08 to 1.2)

Population analysed: Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events (AEs) were collected from Day 1 to 7 postvaccination; unsolicited AEs from Day 1 to Day 22; Serious AEs from Day 1 to Day 366.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aTIV (Pooled)	264 of 3,545 (7.4%)	1,678 of 3,545 (47.3%)	Not reported
Licensed TIV	243 of 3,537 (6.9%)	1,257 of 3,537 (35.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25045825Frey 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

38 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Philippines, Colombia, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV (time frame: Day 22 post vaccination). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01162122, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.