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

Seqirus

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00888381

CSLCT-NHF-09-57

2009-011450-18 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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