A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2014 |
End Date: | April 2015 |
A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.
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 vaccine (bioCSL TIV-1), and a trivalent influenza vaccine
containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years
and above.
virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed
2014/2015 trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine
containing the alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years
and above.
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 that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy
male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day
on-study period with a six month safety follow-up.
Northern Hemisphere influenza immunization season to evaluate the non-inferior immune
response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy
male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day
on-study period with a six month safety follow-up.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
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