Status:
COMPLETED
Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three c...
Eligibility Criteria
Inclusion
- Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.
Exclusion
- Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
- Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
- Known or suspected impairment/alteration of immune function.
- Individuals with a known bleeding diathesis.
- History of Guillain-Barré syndrome.
- Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
- Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
- Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
- Individuals who had received vaccination against seasonal influenza in the previous 6 months.
- Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Individuals providing consent who did not consent to the retention of their serum samples after study completion.
- Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
- Subjects from whom blood could not be drawn at visit 1.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
7109 Patients enrolled
Trial Details
Trial ID
NCT01162122
Start Date
August 1 2010
End Date
November 1 2011
Last Update
June 26 2014
Active Locations (38)
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1
301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A
Phoenix, Arizona, United States, 85253
2
318 Avail Clinical Research, 860 Peachwood Drive
DeLand, Florida, United States, 32720
3
306 Westside Center for Clinical Research, 810 Lane Avenue South
Jacksonville, Florida, United States, 32205
4
328 Miami Research Associates, 6141 Sunset Drive
Miami, Florida, United States, 33143