A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® vaccine in Two Groups of Healthy Volunteers: ‘Adults’ (aged 18 to 59 years) and ‘Older Adults’ (aged 60 years or older).

CSL Limited0 个研究点目标入组 120 人开始时间: 2012年4月19日最近更新: 2012年8月28日

适应症

试验速览

暂无简介。

•1. Males or females aged 18 years or older at the time of vaccination.
•2. Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.
•3. willing and able to adhere to protocol requirements
•4. participants must be capable of understanding the purpose and risks of the study and able to provide written informed consent
•5. able to provide sample of approximately 10 mL venous blood on 2 occasions without undue stress
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1. Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the Enzira vaccine.
•2. Clinical signs of an active infection and/or elevated oral temperature at study entry.
•3. A clinically significant medical or psychiatric condition.
•4. Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
•5. Females who are pregnant or lactating or planning to become pregnant during the study period.
•6. Confirmed or suspected immunosuppressive condition
•7. History of seizures
•8. History of Guillain-Barre syndrome
•9. Currently receiving treatment with warfarin or other anticoagulants
•10. Currently receiving treatment with systemic glucocorticoid therapy or within 3 months preceding Enzira vaccine administration
•11. Currently receiving treatment with radiotherapy or cytotoxic drugs or within 6 months or administration of Enzira vaccine
•12. Currently receiving immunoglobulins and/or blood products or within 3 months of study entry
•13. Currently participating in another investigational study or ended such participation within 1 month of administration of Enzira vaccine

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