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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735475
• Other study ID #: CSLCT-USF-07-41
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
United States	Covance CRU Inc.	Austin	Texas
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Covance CRU, Inc	Boise	Idaho
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	The University of Iowa	Iowa City	Iowa
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	North Central Arkansas Medical Association	Mountain Home	Arkansas
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Primary Physicians Research, Inc.	Pittsburgh	Pennsylvania
United States	Covance CRU, Inc.	Portland	Oregon
United States	University of Rochester School of Medicine and Dentistry	Rochester	New York
United States	Saint Louis University Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer 21 Days After the Study Vaccination		21 days after vaccination
Primary	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	Frequency and Intensity of Local and Systemic Solicited Symptoms		5 days after vaccination
Secondary	Duration of Local and Systemic Solicited Symptoms		5 days after vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	Abbreviation UAE stands for Unsolicited Adverse Event.	21 days after vaccination
Secondary	Serious Adverse Events		180 days after vaccination
Secondary	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