A Phase IV, Randomised, Observer-Blind,Comparator-Controlled, Single-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Influenza Vaccine (Enzira) (2006/2007) in Healthy Older Adults aged >=65 years

Phase 1

• Conditions: Prophylaxis of influenza

• Registration Number: EUCTR2006-004354-24-GB
• Lead Sponsor: CSL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. healthy adults aged >= 65 years at the time of informed consent
2. provides written informed consent and adherence to all protocol requirements
3. is in good health, as determined by medical history and physical examination where indicated
4. is able to understand and comply with planned study procedures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Hypersensitivity to eggs, chicken protein, neomycin, polymyxin, gentamicin sulphate, formaldehyde, sodium deoxycholate, thiomersal or any components of the Study Vaccines;
2. Interpandemic vaccination against influenza or laboratory culture confirmed Influenza in 2006;
3. Vaccination with an experimental influenza vaccine (eg. a candidate pandemic influenza vaccine or a novel influenza vaccine) in 2006;
4. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality;
5. Known history of Guillain-Barré Syndrome;
6. Clinical signs of active infection and/or an oral temperature of >= 38°C (100.4°F). Study entry may be deferred for such individuals, at the discretion of the Principal Investigator (PI);
7. Active neurological disease;
8. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder;
9. Current treatment with warfarin or other anticoagulant;
10. Current (or within the 90 days prior to receiving the Study Vaccines) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
· Chronic or long term corticosteroids: >15mg/day of oral prednisolone or equivalent daily;
· Sporadic corticosteroids: >40mg/day of oral prednisolone or equivalent for more than two courses of >14 days in the three months preceding vaccination;
· Administration of immunogobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study
Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccines or throughout the Study is acceptable.
11. Participation in a clinical trial where the participant received an investigational product or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 30 days prior to receiving the Study Vaccines or plans to enter a clinical trial during the study period;
12. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccines;
13. Current treatment, or treatment with cytotoxic drugs or radiotherapy at any time during the six months prior to administration of the Study Vaccines;
14. Major congenital defects or serious chronic illness;
15. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
16. Unwillingness or inability to comply with the study Protocol;
17. History of psychiatric disorders, which, in the opinion of the Principal Investigator (PI), would prevent participants from giving proper informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified