A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00888381
First received: April 24, 2009
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.


Condition Intervention Phase
Influenza
Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)
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 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).

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 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:
  • The Frequency of Any Solicited Local Reactions. [ 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 local reactions.

  • The Frequency of Any Solicited Systemic Symptoms. [ 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 systemic symptoms.

  • The Incidence of Any Unsolicited Adverse Events (AEs). [ Time Frame: After vaccination until the end of the study; approximately 21 days ] [ Designated as safety issue: Yes ]

    The number of participants reporting any unsolicited adverse events.

    Unsolicited adverse event (UAE) grading:

    Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities.



Enrollment: 120
Study Start Date: May 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adults
Healthy volunteers aged 18 to 59 years
Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)
A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
Other Name: Enzira® vaccine (2009 / 2010 formulation)
Experimental: Older Adults
Healthy volunteers aged 60 years or older
Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)
A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
Other Name: Enzira® vaccine (2009 / 2010 formulation)

  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 at the time of providing informed consent
  • Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
  • Willing and able to adhere to all protocol requirements
  • Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
  • 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

Exclusion Criteria:

  • Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
  • Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
  • A clinically significant medical or psychiatric condition
  • A confirmed or suspected immunosuppressive condition
  • History of seizures
  • History of Guillain-Barré Syndrome
  • Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
  • Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
  • Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
  • Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
  • Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
  • Currently receiving treatment with warfarin or other anticoagulants
  • Evidence or history of substance or alcohol abuse within the 12 months before study entry
  • Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
  • Females who are pregnant or lactating
  • Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888381

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

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00888381     History of Changes
Other Study ID Numbers: CSLCT-NHF-09-57, 2009-011450-18
Study First Received: April 24, 2009
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 April 16, 2014