Phase 4
Completed N=120
A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population
Source: ClinicalTrials.gov NCT01113580 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. — 89.7; 80.0; 89.7; 71.7 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. |
89.7; 80.0; 89.7; 71.7; 63.8; 28.3 | — |
| PRIMARY The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. |
20.48; 12.90; 24.70; 11.53; 6.63; 2.77 | — |
| PRIMARY The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. |
91.4; 90.0; 98.3; 96.7; 89.7; 70.0 | — |
| SECONDARY Frequency of Any Solicited Adverse Events (AEs) |
32; 18; 2; 0; 22; 9 | — |
| SECONDARY Frequency and Intensity of Any Unsolicited Adverse Events |
28; 22; 22; 19; 7; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01113580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.