The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School
Dundee, United Kingdom
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
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.
Time frame: Approximately 21 days after vaccination
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
Time frame: Approximately 21 days after vaccination
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
The Frequency of Any Solicited Local Reactions.
The number of participants reporting any solicited local reactions.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
The Frequency of Any Solicited Systemic Symptoms.
The number of participants reporting any solicited systemic symptoms.
Time frame: During the 4 days after vaccination (Day 0 plus 3 days)
The Incidence of Any Unsolicited Adverse Events (AEs).
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.
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Time frame: After vaccination until the end of the study; approximately 21 days