Status:
COMPLETED
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
Lead Sponsor:
Novartis Vaccines
Conditions:
Interpandemic Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
Trial for annual approval of interpandemic influenza vaccines
Eligibility Criteria
Inclusion
- Key
- 65 years of age or older
- Mentally competent
- Willing and able to give written informed consent prior to study entry
- Able to comply with all the study requirements
- In general good health
- Key
Exclusion
- Any serious chronic or acute disease
- 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, kanamycin and neomycin sulphate);
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
- Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
- A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Within the past 12 months, they have received more than one injection of influenza vaccine
- Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
- Within the past 4 weeks participants had received another vaccine; any investigational agent
- An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00734734
Start Date
June 1 2008
End Date
July 1 2008
Last Update
January 28 2016
Active Locations (2)
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1
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale
Lanciano, Italy, 66034
2
Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano -Via Nazionale 48
Pianiga, Italy, 30034