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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:
ClinicalTrials.gov Identifier:
NCT01591837
First Posted: May 4, 2012
Last Update Posted: August 16, 2016
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
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
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 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 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 (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 ]
    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 ]
    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) ]

    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01591837


Locations
United Kingdom
Study Site
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Seqirus
Investigators
Study Director: Clinical Director Vaccines Seqirus
  More Information

Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT01591837     History of Changes
Other Study ID Numbers: CSLCT-ASU-12-76
2012-001101-24 ( EudraCT Number )
First Submitted: May 3, 2012
First Posted: May 4, 2012
Results First Submitted: June 6, 2013
Results First Posted: November 18, 2013
Last Update Posted: August 16, 2016
Last Verified: October 2013

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs