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
1 other identifier
interventional
1,268
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2008
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
September 1, 2011
CompletedMay 23, 2018
April 1, 2018
3 months
August 13, 2008
July 3, 2011
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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)
21 days after vaccination
Serious Adverse Events
180 days after vaccination
New Onsets of Chronic Illness
180 days after vaccination
Study Arms (2)
Afluria®
EXPERIMENTALFluzone®
ACTIVE COMPARATORInterventions
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Eligibility Criteria
You may qualify if:
- Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
- Written informed consent ;
- Willingness to provide a blood sample.
You may not qualify if:
- 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;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (13)
North Central Arkansas Medical Association
Mountain Home, Arkansas, 72635, United States
Covance CRU, Inc
Boise, Idaho, 83704, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004, United States
Saint Louis University Medical Center
St Louis, Missouri, 63104, United States
University of Rochester School of Medicine and Dentistry
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27704, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Covance CRU, Inc.
Portland, Oregon, 97239, United States
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241, United States
Clinical Partners, LLC
Johnston, Rhode Island, 02919, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232, United States
Covance CRU Inc.
Austin, Texas, 78752, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Disclosure Manager
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Director Vaccines
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2008
First Posted
August 15, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2009
Study Completion
June 1, 2009
Last Updated
May 23, 2018
Results First Posted
September 1, 2011
Record last verified: 2018-04