Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effectiveness, safety, and tolerability of an
      influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world
      in the winter months. Infection with an influenza virus is a major public health threat as it
      has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy
      adults ages 18 to less than 65 years old will participate in this study for up to 24 days.
      Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine
      without thimerosal, or placebo with thimerosal. Volunteers will be asked to document
      information about any health changes for 21 days following vaccination. Volunteers will
      return to the clinic on days 5 and 21 after vaccination to share this information with study
      staff. On day 21, volunteers will have a physical examination. Blood samples will be taken
      prior to vaccination and at Day 21 post-vaccination.
    

Detailed description: 
      The purpose of this Phase III, randomized, double-blinded, placebo-controlled, multi-center
      study is to evaluate the immunogenicity, safety, and tolerability of CSL Limited Inactivated
      Influenza Vaccine in adults ages 18 to less than 65. The primary objective of this study is
      to demonstrate that vaccination with CSL Limited Inactivated Influenza Vaccine produces an
      immune response sufficient to meet the Committee for Medicinal Products for Human Use (CHMP)
      criteria for young adults of 40% serorconversion and 70% seroprotection. Secondary objectives
      are to: demonstrate clinical consistency between 3 lots (batches) of CSL Limited Inactivated
      Influenza Vaccine multi-dose vial presentation (Thimerosal containing); to demonstrate
      clinical consistency between CSL Limited Inactivated Influenza Vaccine multi-dose vial
      presentation (Thimerosal containing) and CSL Limited Inactivated Influenza Vaccine pre-filled
      syringe presentation (Thimerosal-free); and to demonstrate acceptable safety and tolerability
      of CSL Limited Inactivated Influenza Vaccine multi-dose vial presentation (Thimerosal
      containing) and pre-filled syringe presentation (Thimerosal-free). Primary endpoints are
      seroprotection rate and seroconversion rate. Seroprotection is defined as a minimum
      post-vaccination humagglutination inhibition (HI) titer of 1:40, and seroconversion is
      defined as an increase in HI antibody titer of at least 4-fold, with a minimum
      post-vaccination HI titer of 1:40. Secondary endpoints are: comparison of the Geometric Mean
      Titers to influenza hemagglutinin antigens post vaccination of the active treatment arms; and
      the number and rate of the type, frequency and intensity of adverse events (AE) in the active
      treatment arms. Approximately 1250 (and up to 1359) healthy adults, ages 18 to less than 65
      years old, will be enrolled into this clinical trial. Subjects who meet the inclusion
      criteria for the study will be randomized in a 1:1:1:1:1 ratio to receive 1 of 3 lots of
      vaccine in multidose vials, a single lot of vaccine in pre-filled syringes or placebo in
      multi-dose vials (250 subjects per group). Vaccine will be prepared and administered by an
      unblinded vaccine administrator, who will not be involved in subsequent assessments. Subjects
      will be observed in the clinic for at least 30 minutes after vaccination, and subjects will
      maintain a 5-day, post-vaccination solicited AE and local reaction memory aid and a 21-day
      unsolicited AE memory aid. Subjects will return to the clinic at day 5 to review their
      reactogenicity memory aid. Subjects will also return to clinic on Day-21 post-vaccination for
      AE and concomitant medication assessment, a targeted physical examination (if indicated), and
      a review of the memory aid. Serum for antibody titers will be drawn prior to vaccination and
      on Day-21 post-vaccination. Subjects will participate for up to 24 days.
    

Intervention name(s): CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free; CSL Trivalent Inactivated Influenza Vaccine with Thimerosal; Placebo with Thimerosal
Intervention type(s): Biological; Biological; Biological
Intervention description(s): CSL influenza vaccine-prefilled syringe presentation (thimerosal-free) 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.; CSL influenza vaccine-multiple dose vial presentation (thimerosal-containing) containing 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.; Phosphate buffered isotonic saline solution containing thimerosal. Single dose of 0.5 mL administered on study day 0.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: CSL Influenza Vaccine, influenza, vaccine, immunogenicity