Clinical Trials Directory

Trials / Completed

CompletedNCT02214225

A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

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.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
3,484 (actual)
Sponsor
Seqirus · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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 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.

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 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALQuadrivalent Influenza Vaccine (QIV)One 0.5 mL intramuscular dose into the deltoid muscle
BIOLOGICALTrivalent Influenza Vaccine (TIV-1)One 0.5 mL intramuscular dose into the deltoid muscle.
BIOLOGICALTrivalent Influenza Vaccine (TIV-2)One 0.5 mL intramuscular dose into the deltoid muscle.

Timeline

Start date
2014-08-01
Primary completion
2014-11-01
Completion
2015-04-01
First posted
2014-08-12
Last updated
2017-03-13
Results posted
2016-02-23

Locations

33 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02214225. Inclusion in this directory is not an endorsement.