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

April 26, 2010
June 13, 2012
May 2010
May 2010   (final data collection date for primary outcome measure)
  • 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 ]
Immunogenicity of Enzira® vaccine according to the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. [ Time Frame: 21 days after vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01113580 on ClinicalTrials.gov Archive Site
  • 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.

  • Frequency, duration and intensity of solicited adverse events [ Time Frame: During the 3 days after vaccination ] [ Designated as safety issue: Yes ]
  • Frequency, duration and intensity of unsolicited adverse events [ Time Frame: During the 21 days after vaccination ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
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: Adults
    Healthy volunteers aged 18 to 59 years
    Intervention: Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine
  • Experimental: Older Adults
    Healthy volunteers aged 60 years or older
    Intervention: Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01113580
CSLCT-ASU-10-66, 2010-019532-12
No
CSL Limited
CSL Limited
Not Provided
Principal Investigator: Ronnie Beboso, Dr Chiltern (Early Phase) Limited
CSL Limited
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP