Status:
COMPLETED
A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers
Lead Sponsor:
Seqirus
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00888381
Start Date
May 1 2009
End Date
May 1 2009
Last Update
June 28 2018
Active Locations (1)
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1
Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY