Influenza, Human

A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

NCT01863433 | PHASE 4 | INTERVENTIONAL

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.

1 Sites

120 Participants

Recruiting

18 Years to 59 Years

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SUBMIT

Study Site

London,United Kingdom,NW107EW

Study Eligibility Criteria

Inclusion Criteria

* Males or females aged between 18 and 60 years at the time of vaccination.
* 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.

Exclusion Criteria

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.

Additional Studies

Additional studies can be found at ClinicalTrials.gov