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

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Biological: Trivalent Influenza Vaccine (TIV-2); Biological: Quadrivalent Influenza Vaccine (QIV); Biological: Trivalent Influenza Vaccine (TIV-1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02214225

CSLCT-QIV-13-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,484 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,484 participants in 3 patient groups

Quadrivalent Influenza Vaccine (QIV)

Experimental group

Description:

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).

Treatment:

Biological: Quadrivalent Influenza Vaccine (QIV)

Trivalent Influenza Vaccine (TIV-1)

Active Comparator group

Description:

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).

Treatment:

Biological: Trivalent Influenza Vaccine (TIV-1)

Trivalent Influenza Vaccine (TIV-2)

Active Comparator group

Description:

The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season).

Treatment:

Biological: Trivalent Influenza Vaccine (TIV-2)