Status:
COMPLETED
A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivalent influenza...
Detailed Description
This multicenter, randomized, double-blinded study was conducted during the 2014-2015 Northern Hemisphere influenza immunization season to evaluate the non-inferior immune response of bioCSL QIV to th...
Eligibility Criteria
Inclusion
- Males or non-pregnant females aged ≥ 18 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 On-study period. 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 dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.
- Vaccination against influenza in the previous 6 months.
- Known history of Guillain-Barré Syndrome or other demyelinating disease.
- Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).
- A clinically significant medical condition.
- Pregnant or lactating females.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
3484 Patients enrolled
Trial Details
Trial ID
NCT02214225
Start Date
August 1 2014
End Date
April 1 2015
Last Update
March 13 2017
Active Locations (33)
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1
Site 296
Huntsville, Alabama, United States, 35802
2
Site 286
Los Angeles, California, United States, 90036
3
Site 315
San Diego, California, United States, 92108
4
Site 301
Milford, Connecticut, United States, 06460