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Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvanted Influenza Study Vaccine in Adults Aged 18 Years and Above

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ClinicalTrials.gov Identifier: NCT01880697
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : February 3, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
The present study is designed to confirm the safety and immunogenicity of cell-derived, trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization. The vaccine composition will be based on the WHO-recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine. The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Condition or disease Intervention/treatment Phase
Human Influenza Biological: TIVc Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine Produced in Mammalian Cell Culture (Optaflu®) in Healthy Adults
Study Start Date : August 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: TIVc (≥18 to ≤ 60 years) + TIVc (≥ 61 years)
Subjects in each age cohort received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
Biological: TIVc
Trivalent Influenza Virus Vaccine (surface antigen, inactivated, cell-based)




Primary Outcome Measures :
  1. Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc [ Time Frame: Day 22 (vaccination is on day 1) ]

    Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc.

    The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.


  2. Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc [ Time Frame: Day 22 (vaccination is on day 1) ]

    Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc.

    Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.

    The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years.


  3. Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc [ Time Frame: Day 22/day 1 ]
    The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.

  4. Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc [ Time Frame: Day 22 (vaccination is on day 1) ]

    Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc.

    The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years.


  5. Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc [ Time Frame: Day 22 (vaccination is on day 1) ]

    Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc.

    Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer >10 to at least a 4-fold increase in post-vaccination HI antibody titers.

    The related European (CHMP) criterion for the assessment of immunogenicity is met if >40 % for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.


  6. Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc [ Time Frame: Day 22/day 1 ]

    The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc.

    The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years.


  7. Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc [ Time Frame: Day 1 to Day 4 post-vaccination ]
    The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.

  8. Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc [ Time Frame: Day 1 through Day 22 post-vaccination ]
    The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteer ages 18 years or older, mentally competent, willing and able to give written informed consent prior to study entry;
  • Able to comply with all the study requirements; and
  • In good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator

Exclusion Criteria:

  • Had behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study;
  • Had a serious chronic or acute disease (in the judgment of the investigator) including, but not limited to

    • medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years, or localized prostate cancer that has been clinically stable for >2 years without treatment)
    • medically significant advanced congestive heart failure (ie, New York Heart Association [NYHA] class III and IV)
    • chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease [GOLD] stage III and IV)
    • autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that has been clinically stable for ≥5 years)
    • diabetes mellitus type I
    • poorly controlled diabetes mellitus type II
    • advanced arteriosclerotic disease
    • history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (Down's syndrome)
    • acute or progressive hepatic disease
    • acute or progressive renal disease
    • severe neurological (especially Guillain-Barré syndrome) or psychiatric disorder
    • severe asthma
  • Had a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
  • Had a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:

    • receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study,
    • receipt of immunostimulants within the past 6 months,
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
    • suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
  • Had known or suspected drug or alcohol abuse within the past 2 years;
  • Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would have interfered with the safety of the subject;
  • Was not able to comprehend and to follow all required study procedures for the whole period of the study;
  • Had a history or any illness that, in the opinion of the investigator, would have posed additional risk to the subjects because of participation in the study;
  • Had the following within the past 6 months:

    • had any laboratory-confirmed seasonal or pandemic influenza disease
    • received any seasonal or pandemic influenza vaccine
  • Had received any other vaccine within 4 weeks prior to enrollment in this study or who were planning to receive any vaccine during the study;
  • Had acute or chronic infections requiring antiviral therapy within the last 7 days;
  • Had experienced fever (ie, body temperature [preferably oral] ≥38.0°C) within the last 3 days of intended study vaccination;
  • Had participated in any clinical trial with another investigational product 4 weeks prior to first study visit or intended to participate in another clinical study at any time during the conduct of this study;
  • Was part of study personnel or has close family members conducting this study;
  • Had a body mass index (BMI) >35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters);
  • Was pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880697


Locations
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Germany
Rostock University, Department of Tropical Medicine and Infectious Diseases
Ernst Heydemann Strasse 6, Rostock, Germany, 18057
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines

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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01880697     History of Changes
Other Study ID Numbers: V58_33S
2013-000621-30 ( EudraCT Number )
First Posted: June 19, 2013    Key Record Dates
Results First Posted: February 3, 2014
Last Update Posted: February 23, 2017
Last Verified: December 2013
Keywords provided by Novartis ( Novartis Vaccines ):
Influenza
adults
elderly
immunology
safety
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs