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

This study has been completed.
Information provided by (Responsible Party):
Seqirus Identifier:
First received: April 26, 2010
Last updated: July 17, 2016
Last verified: June 2012
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.

Condition Intervention Phase
Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel 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 2010/2011 Formulation of Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older)

Further study details as provided by Seqirus:

Primary Outcome Measures:
  • The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. [ Time Frame: Approximately 21 days after vaccination ]
    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 ]
    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 ]

Secondary Outcome Measures:
  • Frequency of Any Solicited Adverse Events (AEs) [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ]
    The number of participants reporting any solicited AEs.

  • Frequency and Intensity of Any Unsolicited Adverse Events [ Time Frame: After vaccination until the end of the study; approximately 21 days ]

    Unsolicited adverse event (UAE) grading:

    Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities.

Enrollment: 120
Study Start Date: May 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adults
Healthy volunteers aged 18 to 59 years
Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine
45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0
Experimental: Older Adults
Healthy volunteers aged 60 years or older
Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine
45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01113580

United Kingdom
Chiltern (Early Phase) Limited
Dundee, Angus and Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Principal Investigator: Ronnie Beboso, Dr Chiltern (Early Phase) Limited
  More Information

Responsible Party: Seqirus Identifier: NCT01113580     History of Changes
Other Study ID Numbers: CSLCT-ASU-10-66
2010-019532-12 ( EudraCT Number )
Study First Received: April 26, 2010
Results First Received: June 13, 2012
Last Updated: July 17, 2016

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017