Influenza

A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

NCT00888381 | PHASE 4 | INTERVENTIONAL

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

1 Sites

120 Participants

Recruiting

18 Years to 65 Years

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SUBMIT

Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School

Dundee,United Kingdom,DD19SY

Study Eligibility Criteria

Inclusion Criteria

* Males or females aged ≥ 18 years at the time of providing informed consent
* Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
* Willing and able to adhere to all protocol requirements
* Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
* 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

Exclusion Criteria

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
* Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
* A clinically significant medical or psychiatric condition
* A confirmed or suspected immunosuppressive condition
* History of seizures
* History of Guillain-Barré Syndrome
* Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
* Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
* Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
* Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
* Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
* Currently receiving treatment with warfarin or other anticoagulants
* Evidence or history of substance or alcohol abuse within the 12 months before study entry
* Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
* Females who are pregnant or lactating
* Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation

Additional Studies

Additional studies can be found at ClinicalTrials.gov