Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

Completed · Phase 3

Conditions studied: Influenza

In brief

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 consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.

Key facts

Study ID

NCT01162122

Run by

Novartis Vaccines

People needed

7109

Starts

2010-08-01

Expected to finish

2011-11-01

Last updated by the study team

2014-06-26

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females subjects aged ≥65 years at day of vaccination who are willing and able to comply to study procedures.

You may not qualify if…

• 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.

Where it is running

• 301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A — Phoenix, Arizona, United States
• 318 Avail Clinical Research, 860 Peachwood Drive — DeLand, Florida, United States
• 306 Westside Center for Clinical Research, 810 Lane Avenue South — Jacksonville, Florida, United States
• 328 Miami Research Associates, 6141 Sunset Drive — Miami, Florida, United States
• 320 Johnson County Clin-Trials, 15602 College Blvd — Lenexa, Kansas, United States
• 316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr — Newton, Kansas, United States
• 310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600 — Wichita, Kansas, United States
• 322 Heartland Research Associates Wichita, 1709 S. Rock Road — Wichita, Kansas, United States
• 314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827 — St Louis, Missouri, United States
• 330 Mercy Health Research, 12680 Olive Blvd Suite 200 — St Louis, Missouri, United States
• 313 Clinical Research Center of Nevada, 7425 W Azure Suite 150 — Las Vegas, Nevada, United States
• 311 Regional Clinical Research INC, 415 Hooper Road — Endwell, New York, United States
• 326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104 — Raleigh, North Carolina, United States
• 332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306 — Winston-Salem, North Carolina, United States
• 303 Prestige Clinical Research, 333 Conover Drive — Franklin, Ohio, United States
• 325 Omega Medical Research, 400 Bald Hill Road — Warwick, Rhode Island, United States
• 312 Spartanburg Regional Medical Center, 485 Simuel Road — Spartanburg, South Carolina, United States
• 321 Jordan River Family Medicine, 1868 West 9800 South Ste 100 — Jordan, Utah, United States
• 317 J. Lewis Research Inc., 2295 Foothill Drive — Salt Lake City, Utah, United States
• 305 Foothill Family Clinic South, 6360 South 3000 East — Salt Lake City, Utah, United States
• 323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500 — Fairfax, Virginia, United States
• 209, Centro de Investigacion CAFAM — Avenida Carrera 68, Bogota D.C., Colombia
• 206, Centro de Atencion e Investigacion Medica CAIMED — Carrera 42A, Bogota D.C., Colombia
• 213, Centro de Atencion e Investigacion Medica CAIMED — Carrera 42A, Bogota D.C., Colombia
• 207, Centro de Investigacion Cafesalud Medicina Prepagada — Cra 14 No Piso Sexto, Bogota D.C., Colombia

Full record on ClinicalTrials.gov

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