A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: CSL Limited Influenza Virus Vaccine (Afluria®); Biological: US Licensed Influenza Virus Vaccine (Fluzone®)

• Study Type: Interventional
• Enrollment (Actual): 1268
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Mountain Home, Arkansas, United States, 72635
      • North Central Arkansas Medical Association
  • Idaho
    • Boise, Idaho, United States, 83704
      • Covance CRU, Inc
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatric/ Adult Research
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Medical Center
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester School of Medicine and Dentistry
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Covance Cru, Inc.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Primary Physicians Research, Inc.
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Texas
    • Austin, Texas, United States, 78752
      • Covance CRU Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
2. Written informed consent ;
3. Willingness to provide a blood sample.

Exclusion Criteria:

1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
2. Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
3. Known history of Guillain-Barré Syndrome;
4. Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
5. Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
6. History of seizures;
7. Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
8. Clinically significant history of malignancy
9. Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
10. Current immunosuppressive or immunomodulative therapy;
11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
12. Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
13. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
14. Current treatment with warfarin or other anticoagulants;
15. Major congenital defects;
16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
17. Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
18. History of psychiatric disorders;
19. Resident of long term care facility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afluria®	Biological: CSL Limited Influenza Virus Vaccine (Afluria®); A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Active Comparator: Fluzone®	Biological: US Licensed Influenza Virus Vaccine (Fluzone®); A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer 21 Days After the Study Vaccination		21 days after vaccination
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.	21 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Intensity of Local and Systemic Solicited Symptoms		5 days after vaccination
Duration of Local and Systemic Solicited Symptoms		5 days after vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAEs)	Abbreviation UAE stands for Unsolicited Adverse Event.	21 days after vaccination
Serious Adverse Events		180 days after vaccination
New Onsets of Chronic Illness	A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).	180 days after vaccination

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Clinical Director Vaccines, Seqirus

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CSLCT-USF-07-41