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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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