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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:
ClinicalTrials.gov Identifier:
NCT01113580
First Posted: April 30, 2010
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seqirus
  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
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113580


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

Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT01113580     History of Changes
Other Study ID Numbers: CSLCT-ASU-10-66
2010-019532-12 ( EudraCT Number )
First Submitted: April 26, 2010
First Posted: April 30, 2010
Results First Submitted: June 13, 2012
Results First Posted: July 18, 2012
Last Update Posted: November 21, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs