Who is sponsoring NCT02214225?

NCT02214225 is sponsored by Seqirus.

What condition does NCT02214225 study?

NCT02214225 studies Influenza, Human.

What drugs are being tested in NCT02214225?

Interventions: Quadrivalent Influenza Vaccine (QIV), Trivalent Influenza Vaccine (TIV-1), Trivalent Influenza Vaccine (TIV-2).

What is the status of NCT02214225?

NCT02214225 is currently COMPLETED.

Last reviewed 2017-01-31 · How we verify

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.

NCT02214225 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Seqirus
Phase	Phase 3
Status	COMPLETED
Enrolment	3484
Start date	2014-08
Completion	2015-04

Conditions

Influenza, Human

Interventions

Quadrivalent Influenza Vaccine (QIV)
Trivalent Influenza Vaccine (TIV-1)
Trivalent Influenza Vaccine (TIV-2)

Primary outcomes

Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population). — 21 days after vaccination.
Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years. — 21 days after vaccination.
SCR (defined as the percentage of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.

Countries

United States