A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

Seqirus

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113580

2010-019532-12 (EudraCT Number)

CSLCT-ASU-10-66

Details and patient eligibility

About

The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female aged 18 years and older at the time of the first study vaccination.

Exclusion criteria

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
• Clinical signs of an active infection
• 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

Experimental group

Description:

Healthy volunteers aged 18 to 59 years

Treatment:

Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

Older Adults

Experimental group

Description:

Healthy volunteers aged 60 years or older

Treatment:

Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine