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

COMPLETED

18 Years

If interested, contact clinicaltrials@cslbehring.com or +1 610-878-4697 for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

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