A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers

Seqirus

Status and phase: Completed; Phase 4

Conditions: Influenza, Human

Treatments: Biological: Enzira® vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857297

2013-000945-37 (EudraCT Number)

CSLCT-ASU-12-82

Details and patient eligibility

About

This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females aged 18 years or older 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 study. 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 vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
• Clinical signs of an active infection.
• A clinically significant medical condition.
• Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
• Females who are pregnant or lactating.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Adults (aged 18 to 59 years)

Experimental group

Description:

The study vaccine (Enzira® vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.

Treatment:

Biological: Enzira® vaccine

Older Adults (aged 60 years or older)

Experimental group

Description:

The study vaccine (Enzira® vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2013/2014 influenza season). The vaccine will be administered by intramuscular or deep subcutaneous injection.

Treatment:

Biological: Enzira® vaccine