Status:
COMPLETED
Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009
Detailed Description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples wer...
Eligibility Criteria
Inclusion
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- available for all the visits scheduled in the study and able to comply with all study requirements
- in good health as determined by:
- medical history
- physical examination
- clinical judgment of the investigator
Exclusion
- Any serious (in the judgment of the investigator) disease including, but not limited to:
- Cancer, except for localized skin cancer
- Advanced congestive heart failure
- Chronic obstructive pulmonary disease (COPD
- Autoimmune disease (including rheumatoid arthritis)
- Acute or progressive hepatic disease
- Acute or progressive renal disease
- Severe neurological or psychiatric disorder
- Severe asthma
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin, polymixin)
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:
- Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study
- Receipt of immunostimulants,
- Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
- Suspected or known HIV infection or HIV-related disease.
- Known or suspected history of drug or alcohol abuse.
- The subject has a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Women who are pregnant or woman of child-bearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
- Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
- Within the past 4 weeks, the subject has received:
- another vaccine
- any investigational agent
- Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- The subject has experienced an acute exacerbation of a COPD within the past 14 days
- The subject has experienced fever (i.e. axillary temperature ³ 38.0°C) within the last 3 days
- Severely obese with Body Mass Index (BMI) \> 35 kg/m2
- Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00748150
Start Date
July 1 2008
End Date
August 1 2008
Last Update
January 5 2012
Active Locations (1)
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1
The Health Centre
Heath Road, Woolpit, Bury Saint Edmunds, Suffolk, United Kingdom, IP309QU