Status:
COMPLETED
A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
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 vol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01863433
Start Date
May 1 2013
End Date
June 1 2013
Last Update
June 28 2018
Active Locations (1)
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1
Study Site
London, United Kingdom, NW10 7EW