Phase 4
Completed N=120
A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers
Source: ClinicalTrials.gov NCT00888381 ↗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. — 91.7; 53.4; 93.3; 63.8 percentage of participants
Summary
The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. |
91.7; 53.4; 93.3; 63.8; 76.7; 46.6 | — |
| PRIMARY The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. |
27.86; 5.02; 30.32; 9.80; 12.85; 6.13 | — |
| PRIMARY The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. |
100.0; 91.4; 100.0; 94.8; 85.0; 60.3 | — |
| SECONDARY The Frequency of Any Solicited Local Reactions. |
32; 22; 1; 2; 22; 12 | — |
| SECONDARY The Frequency of Any Solicited Systemic Symptoms. |
7; 5; 1; 0; 6; 2 | — |
| SECONDARY The Incidence of Any Unsolicited Adverse Events (AEs). |
25; 21; 20; 21; 12; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00888381). 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.