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Safety and Immunogenicity of Enzira 2010/2011 Influenza Vaccine
NCT01113580Phase 4
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- May 2010
- Countries
- 1
- Sponsor
- CSL Seqirus
- Modality
- Small Molecules
- Drugs
- Afluria
- Conditions
- influenza
01
Overview
Phase 4, open-label trial of Afluria in influenza (2 arms), sponsored by CSL Seqirus. Primary endpoints: Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre at 21 days, Geometric Mean Fold Increase (GMFI) in Antibody Titre at 21 days and 1 more. Started May 2010; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Adults (18-59 years)
Healthy volunteers aged 18 to 59 years receiving Enzira vaccine
Older Adults (60+ years)
Healthy volunteers aged 60 years or older receiving Enzira vaccine
03
Who it enrols
Healthy male or female volunteers aged 18 years and older, excluding those with hypersensitivity to vaccine components (eggs, chicken protein, neomycin, polymyxin), active infection, recent influenza vaccination, or pregnancy/lactation.
04
Endpoints
Primary
Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre
Geometric Mean Fold Increase (GMFI) in Antibody Titre
Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2
Secondary
Frequency of Any Solicited Adverse Events (AEs)
Frequency and Intensity of Any Unsolicited Adverse Events
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