Enhanced Influenza Vaccines in Chronic Disease Study
Phase 1
Active, not recruiting
- Conditions
- Heart diseaseChronic Obstructive Pulmonary DiseaseDiabetes MellitusChronic renal diseaseOld ageRespiratory - AsthmaCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemPublic Health - Other public health
- Registration Number
- ACTRN12608000364370
- Lead Sponsor
- Vaxine pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Diagnosis of chronic obstructive pulmonary disease, diabetes mellitus, cardiovascular disease or chronic renal disease or age 60 years or greater
Exclusion Criteria
History of vaccination with current (2008) season influenza vaccine, History of vaccine or egg allergy, Women of childbearing potential unless using a reliable and appropriate contraceptive method, specifically oral contraceptive pill, intrauterine device or mechanical barrier device, Pregnant or lactating women, Concurrent immunosuppressive therapy, including corticosteroids (with the exception of topically applied/inhaled steroids), Individuals with a known infection of human immunodeficiency virus (HIV), History of intravenous drug abuse or alcohol abuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity as assessed by haemagglutination inhibition assay (HAI)[3-4 weeks post vaccination];Safety as assessed by local (e.g. injection site reactions including pain, swelling, erythema) and systemic adverse events (e.g. fever, nausea, myalgia) as recorded in subject diaries and routine biochemical and haematological screening assays[3 weeks post vaccination]
- Secondary Outcome Measures
Name Time Method Influenza-related morbidity as assessed by incidence of respiratory infections, hospitalisations and unscheduled general practitioner or emergency department visits need for antibiotic therapy.[3, 6, and 12 months post vaccination]