Clinical Trial: Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza

Brief Summary: Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome:

  • Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) [ Time Frame: Day 1 and 43 ]
    Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
  • Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) [ Time Frame: Day 43 ]
    Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
  • Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) [ Time Frame: Day 43 ]

    Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.

    Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.

  • Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) [ Time Frame: Day 1 and 43 ]
    Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
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    Original Primary Outcome:

    • Geometric Mean Titre (GMT), Geometric Mean Ration (GMR) and percentage of subjects achieving seroconversion [ Time Frame: Day 1 and 43 ]
      To evaluate hemagglutination inhibition (HI) assay results for each H7N9 vaccine group after 2 vaccine doses, with descriptive summaries of the endpoints for Day 43.
    • Percentage of subjects with solicited local adverse events [ Time Frame: Day 1-7 ]
      To evaluate the safety and tolerability of each H7N9 vaccine group.
    • Percentage of subjects with solicited systematic adverse events [ Time Frame: Day 22-29 ]
      To evaluate the safety and tolerability of each H7N9 vaccine group.
    • Percentage of subjects with unsolicited adverse events and percentage of subjects with serious adverse events [ Time Frame: Day 1-336 ]
      To evaluate the safety and tolerability of each H7N9 vaccine group.


    Current Secondary Outcome:

    • Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) [ Time Frame: Day 1 and 22 ]
      Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
    • Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) [ Time Frame: Day 22 ]
      GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
    • Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) [ Time Frame: Day 22 ]

      Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.

      Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.

    • Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) [ Time Frame: Day 1 and 22. ]
      Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
    • Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) [ Time Frame: Day 183 and 366. ]
      The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
    • Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) [ Time Frame: Day 183 and 366 ]
      GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
    • Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) [ Time Frame: Day 183 and 366 ]

      Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.

      Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.

    • Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) [ Time Frame: Day 183 and 366 ]
      Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.


    Original Secondary Outcome:

    • GMT, GMR and percentage of subjects achieving seroconversion by HI [ Time Frame: Day 1, 22, 183, 366 ]
      To evaluate hemagglutination inhibition (HI) assay results for each H7N9c vaccine group at Day 22 and To evaluate hemagglutination inhibition (HI) assay results for each H7N9c vaccine group for persistence at 6 and 12 months
    • GMT, GMR and percentage of subjects achieving seroconversion by MN [ Time Frame: Day 1, 22, 43, 183, 366 ]
      Microneutralization (MN) and other serologic assays for H7N9 may be evaluated


    Information By: Novartis

    Dates:
    Date Received: August 21, 2013
    Date Started: August 2013
    Date Completion:
    Last Updated: May 5, 2015
    Last Verified: May 2015