Expired Study
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Durham, North Carolina 27704


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

CSLCT-USF-07-41


NCT ID:

NCT00735475


Secondary ID:


Study Acronym:


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 Vir


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 6


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Seqirus


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1268


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Director Vaccines
Study Director
Seqirus

Study Dates

Start Date:October 2008
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 25, 2018
First Received Date:August 13, 2008
First Results Date:July 3, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:New Onsets of Chronic Illness
Time Frame:180 days after vaccination
Safety Issues:False
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).
Outcome Type:Secondary Outcome
Measure:Serious Adverse Events
Time Frame:180 days after vaccination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Time Frame:21 days after vaccination
Safety Issues:False
Description:Abbreviation UAE stands for Unsolicited Adverse Event.
Outcome Type:Secondary Outcome
Measure:Duration of Local and Systemic Solicited Symptoms
Time Frame:5 days after vaccination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Frequency and Intensity of Local and Systemic Solicited Symptoms
Time Frame:5 days after vaccination
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percentage of Participants With Seroconversion 21 Days After the Study Vaccination
Time Frame:21 days after vaccination
Safety Issues:False
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-
Outcome Type:Primary Outcome
Measure:Geometric Mean Titer 21 Days After the Study Vaccination
Time Frame:21 days after vaccination
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:CSL Limited Influenza Virus Vaccine (Afluria®)
Description:A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Arm Name:Afluria®
Intervention Type:Biological
Name:US Licensed Influenza Virus Vaccine (Fluzone®)
Description:A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Arm Name:Fluzone®

Study Arms

Study Arm Type:Active Comparator
Arm Name:Fluzone®
Study Arm Type:Experimental
Arm Name:Afluria®

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Seqirus

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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