Status:
COMPLETED
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Seasonal Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This is a trial for annual registration of the updated seasonal influenza vaccine formulation.
Eligibility Criteria
Inclusion
- Key
- Subjects of 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 disease
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
- A proven hypersensitivity to any component of the study vaccine
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
- Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
- Within the past 12 months, participants had received more than one injection of influenza vaccine
- Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00956761
Start Date
June 1 2009
End Date
June 1 2009
Last Update
January 27 2016
Active Locations (2)
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1
Site 2: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, Italy, 66034
2
Site 3: Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48
Pianiga, Italy, 30034