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Completed

NCT Number: NCT00888381

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inactivated Influenza Vaccine (2009 / 2010 formulation)

Biological

A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.

Other names: Enzira® vaccine (2009 / 2010 formulation)

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. The Frequency of Any Solicited Local Reactions.

    Time frame: During the 4 days after vaccination (Day 0 plus 3 days)

    The number of participants reporting any solicited local reactions.

  2. The Frequency of Any Solicited Systemic Symptoms.

    Time frame: During the 4 days after vaccination (Day 0 plus 3 days)

    The number of participants reporting any solicited systemic symptoms.

  3. The Incidence of Any Unsolicited Adverse Events (AEs).

    Time frame: After vaccination until the end of the study; approximately 21 days

    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.

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2009
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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