A Single Centre, Open-Label Study to Evaluate the Immunogenicity and Safety of Enzira® vaccine in Healthy ‘Adults’ aged = 18 to < 60 years and in Healthy ‘Older Adults’ aged = 60 years for the 2008/2009 Northern Hemisphere Influenza Seaso

• Conditions: Prophylaxis of influenza; MedDRA version: 9.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2008-005324-93-GB
• Lead Sponsor: CSL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Healthy males or females, aged = 18 years at the time of providing informed consent.
2. Provision of written informed consent to participate in the study and willingness to adhere to all Protocol requirements.
3. Be able to provide a sample of up to 17 ml of venous blood on two separate occasions without undue distress/discomfort.
4. Negative pregnancy test at enrolment before receiving Study Vaccine (female participants of child-bearing potential ONLY). Those at risk of pregnancy during the study period must, in the opinion of the Investigator, be taking/using adequate methods of contraception. Adequate methods are defined as:
• Oral contraception
• Intrauterine contraceptive device
• Depot contraceptive (implants/injectables)
• Abstinence
• Partner Vasectomy
• Condoms with spermicide.

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, or any components of the vaccine.
2. Vaccination against influenza within the previous 6 months.
3. Clinical signs of active infection and/or an oral temperature of = 38oC at study entry. Study entry may be deferred for such individuals, at the discretion of the PI/delegate.
4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder.
5. Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
• Chronic or long-term corticosteroids: = 15 mg/day of oral prednisolone or equivalent daily.
• Sporadic corticosteroids: = 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the three months preceding vaccination.
Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable.
6. Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or plans to enter a study during the study period.
7. Vaccination with any registered vaccine within 30 days prior to receiving the Study Vaccine.
8. Current treatment, or treatment with cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine.
9. Known history of Guillain-Barré Syndrome.
10. Active neurological disease.
11. Current treatment with warfarin or other anticoagulant;
12. Physical/Medical history that the Investigator feels may adversely affect the participant or study results.
13. Evidence, or history (within the previous 12 months) of drug or alcohol abuse.
14. Unwillingness or inability to comply with the study Protocol.
15. History of psychiatric disorders, which, in the opinion of the Principal Investigator, would prevent the participant from giving proper informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the immunogenicity of Enzira® vaccine in healthy ‘Adults’ aged = 18 to < 60 years of age and in healthy ‘Older Adults’ aged = 60 years of age according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines.;Secondary Objective: To evaluate the safety of Enzira® vaccine in healthy ‘Adults’ aged = 18 to < 60 years of age and in healthy ‘Older Adults’ aged = 60 years of age through:<br>• The assessment of the frequency of solicited local reactions and general symptoms for 3 days following vaccination.<br>• The assessment of unsolicited adverse events (AEs) of more than 2 days duration.<br>;Primary end point(s): To meet at least one of the three immunogenicity criteria, applicable for each strain, as defined in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines.