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: October 25, 2013
Last verified: October 2013
  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: 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 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:


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 (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was 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 (H1N1, H3N2, and B influenza virus strains) was 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 ]
    For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.


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 participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only.

    Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site.

    Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise.

    Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented 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 participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.


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)
Arms Assigned Interventions
Experimental: Adults
Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
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
Experimental: Older Adults
Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
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
Results First Received: June 6, 2013
Last Updated: October 25, 2013
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 April 17, 2014