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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.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT01113580
First received: April 26, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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)

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 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 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 ] [ Designated as safety issue: Yes ]

    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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113580

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

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT01113580     History of Changes
Other Study ID Numbers: CSLCT-ASU-10-66, 2010-019532-12
Study First Received: April 26, 2010
Results First Received: June 13, 2012
Last Updated: June 13, 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 May 23, 2013