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Completed

NCT Number: NCT01162122

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

209, Centro de Investigacion CAFAM, Avenida Carrera 68, Bogota D.C., Colombia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

Biological

one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm

Other names: Fluad

Non-adjuvanted trivalent subunit influenza vaccine (TIV)

Biological

one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Other names: Agriflu

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Secondary outcomes

  1. Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS

    Time frame: Day 22 post vaccination

    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.

  2. 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

    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.

  3. Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS

    Time frame: Day 22 post vaccination

    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.

  4. 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

    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.

  5. Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS

    Time frame: Day 22 post vaccination

    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 .

  6. Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS

    Time frame: Day 22 post vaccination

    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.

  7. 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

    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.

  8. Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS

    Time frame: Day 22 post vaccination

    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.

  9. Persistence of GMTs Against Homologous and Heterologous Strains

    Time frame: Day 181, Day 366 post vaccination

    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.

  10. Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains

    Time frame: Day 181, Day 366 post vaccination

    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.

  11. Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups

    Time frame: Day 22 through Day 366 post vaccination

    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.

  12. Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups

    Time frame: Day 1 through Day 366 post vaccination

    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.

  13. Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups

    Time frame: Day 1 through Day 366 post vaccination

    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.

  14. All Cause Mortality Rate, Across Vaccine Groups

    Time frame: Day 1 through Day 366 post vaccination

    The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.

  15. Number of Subjects Reporting Solicited Adverse Events Following Vaccination

    Time frame: Day 1 through Day 7 post vaccination

    The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2010
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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