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Completed

NCT Number: NCT01113580

A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

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.

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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

Dundee, Angus and 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

  • 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

Treatment and study plan

CSL's 2010/2011 Formulation of Enzira® Vaccine

Biological

45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0

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. 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.

  2. 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.

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 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)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2010
Registry last updated
Nov 21, 2017

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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