Status:
UNKNOWN
Study of Parenterally Administrated Adjuvanted Seasonal Influenza Vaccine in Healthy Elderly Volunteers
Lead Sponsor:
Isconova AB
Conditions:
Influenza
Eligibility:
All Genders
65-75 years
Phase:
PHASE1
Brief Summary
The safety of parenterally administrated investigational vaccine (commercial influenza vaccine formulated with adjuvant Matrix M) in healthy adults (age 18-50) and healthy elderly (age 65-75), will be...
Eligibility Criteria
Inclusion
- Are aged 18 to 50 years for the young adult part of the study
- Are aged 65 to 75 years for main study
- Have signed a voluntary written informed consent. Volunteers should be cooperative, willing and able to participate and adhere to the Protocol requirements
- Have minimum normal standard physical performance status
Exclusion
- Volunteer has received seasonal Influenza vaccine of same antigenic composition within 6 months prior to enrolment
- Volunteer having vaccine specific HI titres ≥ 40
- Volunteer is taking immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc
- Volunteers who have primary or secondary immunodeficiencies (e.g. Human Immunodeficiency Virus \[HIV\])
- Volunteers who have an autoimmune disease
- Volunteer is taking oral, intramuscular or intravenous corticosteroids. Use is not permitted within 1 month of Screening. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease \[COPD\]), are permitted
- Volunteer has a concurrent severe or uncontrolled underlying medical disease unrelated but that is likely to compromise volunteer safety and affect the outcome of the study
- Volunteer has a neurotoxicity (Grade ≥2)
- Volunteer has diarrhoea (Grade ≥2)
- Volunteer has received other vaccines, within 1 month prior to enrolment
- Volunteer has a history of any severe or life-threatening hypersensitivity reaction
- Volunteer has an unstable systemic disease (including active infection, uncontrolled hypertension \[\> 160/100\], unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and metabolic disease)
- Volunteer has recent history (within 6 months) of chronic alcohol or drug abuse of which may compromise the patient's safety or ability to participate in study activities
- Volunteer has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions
- Volunteer is currently enrolled in an investigational device or drug trial, or \< 1 month since completing an investigational device or drug trial
- Female volunteers who are pregnant or lactating (only applicable for Pre-Study)
- Volunteer has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01444482
Start Date
May 1 2011
Last Update
September 30 2011
Active Locations (1)
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1
Drug Reseach Center
Balatonfüred, Balatonfured, Hungary, 8231