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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CSL Limited Influenza Virus Vaccine (Afluria®)
US Licensed Influenza Virus Vaccine (Fluzone®)
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • North Central Arkansas Medical Association
  • Covance CRU, Inc
  • The University of Iowa
  • Kentucky Pediatric/ Adult Research
  • Saint Louis University Medical Center
  • University of Rochester School of Medicine and Dentistry
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Covance CRU, Inc.
  • Primary Physicians Research, Inc.
  • Clinical Partners, LLC
  • Vanderbilt Medical Center
  • Covance CRU Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Afluria®

Fluzone®

Arm Description

Outcomes

Primary Outcome Measures

Geometric Mean Titer 21 Days After the Study 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.

Secondary Outcome Measures

Frequency and Intensity of Local and Systemic Solicited Symptoms
Duration of Local and Systemic Solicited Symptoms
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Abbreviation UAE stands for Unsolicited Adverse Event.
Serious Adverse Events
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).

Full Information

First Posted
August 13, 2008
Last Updated
April 25, 2018
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT00735475
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Afluria®
Arm Type
Experimental
Arm Title
Fluzone®
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
CSL Limited Influenza Virus Vaccine (Afluria®)
Intervention Description
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Intervention Type
Biological
Intervention Name(s)
US Licensed Influenza Virus Vaccine (Fluzone®)
Intervention Description
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Primary Outcome Measure Information:
Title
Geometric Mean Titer 21 Days After the Study Vaccination
Time Frame
21 days after vaccination
Title
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
Description
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.
Time Frame
21 days after vaccination
Secondary Outcome Measure Information:
Title
Frequency and Intensity of Local and Systemic Solicited Symptoms
Time Frame
5 days after vaccination
Title
Duration of Local and Systemic Solicited Symptoms
Time Frame
5 days after vaccination
Title
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Description
Abbreviation UAE stands for Unsolicited Adverse Event.
Time Frame
21 days after vaccination
Title
Serious Adverse Events
Time Frame
180 days after vaccination
Title
New Onsets of Chronic Illness
Description
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).
Time Frame
180 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ; Written informed consent ; Willingness to provide a blood sample. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines; Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine; Known history of Guillain-Barré Syndrome; Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C). Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders; History of seizures; Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder; Clinically significant history of malignancy Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine; Current immunosuppressive or immunomodulative therapy; Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine; Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ; Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine. Current treatment with warfarin or other anticoagulants; Major congenital defects; Evidence, or history (within the previous 12 months) of drug or alcohol abuse; Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards; History of psychiatric disorders; Resident of long term care facility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director Vaccines
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
North Central Arkansas Medical Association
City
Mountain Home
State/Province
Arkansas
ZIP/Postal Code
72635
Country
United States
Facility Name
Covance CRU, Inc
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kentucky Pediatric/ Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Saint Louis University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Rochester School of Medicine and Dentistry
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Covance CRU, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Primary Physicians Research, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Covance CRU Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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