A Single Site, Open-Label Study to Evaluate the Immunogenicity and Safety of Enzira in Healthy 'Adults' aged >18 to <60 years and in Healthy 'Older Adults' aged >60 years for the 2006/2007 Northern Hemisphere Influenza Seaso
- Conditions
- Prophylaxis of influenza
- Registration Number
- EUCTR2006-002068-25-GB
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 20 mL of venous blood 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
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 >38C 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 more than 2 courses of >14 days in the three months preceding vaccination. Note that 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 product (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-Barre Syndrome
10. Active neurological disease
11. Current treatment with warfarin or other anticoagulant
12. Physical/medical history that the investigator feels may 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 disorers 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 in healthy 'Adults' aged >18 years 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 ;<br> Secondary Objective: To evaluate the safety of Enzira in healthy 'adults' aged >18 to <60 years of age and in healthy 'older adults' aged >60 years through:<br><br> the assessment of the frequency of solicited local reactions and general symptoms for 3 days following vaccination<br><br> the assessment of unsolicited adverse events of more than 2 days duration<br> ;Primary end point(s): To meet the criteria defined in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines
- Secondary Outcome Measures
Name Time Method