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A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01591837
First received: May 3, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.


Condition Intervention Phase
Influenza, Human
 Biological: CSL Influenza Vaccine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2012/2013 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • The percentage of evaluable participants achieving seroconversion or significant increase in antibody titre. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]
    As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.

  • The geometric mean fold increase (GMFI) in antibody titre after vaccination. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]
    GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.

  • The percentage of evaluable participants achieving a HI titre ≥ 40 or single radial haemolysis (SRH) area ≥ 25 mm2. [ Time Frame: Approximately 21 days after vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and intensity of any solicited adverse events (AEs). [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ] [ Designated as safety issue: Yes ]

    The percentage of subjects reporting any solicited AEs and the percentage of subjects reporting any solicited AEs with severe intensity.

    Solicited AE intensity grading: Mild: symptoms are easily tolerated and there is no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevent normal, everyday activities.


  • Frequency of any unsolicited AEs. [ Time Frame: After vaccination until the end of the study; approximately 21 days ] [ Designated as safety issue: Yes ]
    The percentage of subjects reporting any unsolicited AEs


Enrollment: 120
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: CSL Influenza Vaccine
    The study vaccine (CSL Influenza 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 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.
    Other Names:
    • Enzira® vaccine
    • Afluria® vaccine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591837

Locations
United Kingdom
Study Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
CSL Limited
Investigators
Study Director: Global Clinical Program Director CSL Limited
  More Information

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01591837     History of Changes
Other Study ID Numbers: CSLCT-ASU-12-76, 2012-001101-24
Study First Received: May 3, 2012
Last Updated: June 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013