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

NCT ID: NCT01162122

Last Updated: 2014-06-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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aTIV

Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).

Group Type EXPERIMENTAL

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

Intervention Type BIOLOGICAL

one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm

Licensed TIV

Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).

Group Type EXPERIMENTAL

Non-adjuvanted trivalent subunit influenza vaccine (TIV)

Intervention Type BIOLOGICAL

one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Interventions

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MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm

Intervention Type BIOLOGICAL

Non-adjuvanted trivalent subunit influenza vaccine (TIV)

one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm

Intervention Type BIOLOGICAL

Other Intervention Names

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Fluad Agriflu

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
3. Known or suspected impairment/alteration of immune function.
4. Individuals with a known bleeding diathesis.
5. History of Guillain-Barré syndrome.
6. 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).
7. 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.
8. 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.
9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
11. Individuals with history of substance or alcohol abuse within the past 2 years.
12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
13. 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.
14. Subjects from whom blood could not be drawn at visit 1.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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301, Tatum Highlands Medical Associates PLLC, 26224 N Tatum Blvd 15A

Phoenix, Arizona, United States

Site Status

318 Avail Clinical Research, 860 Peachwood Drive

DeLand, Florida, United States

Site Status

306 Westside Center for Clinical Research, 810 Lane Avenue South

Jacksonville, Florida, United States

Site Status

328 Miami Research Associates, 6141 Sunset Drive

Miami, Florida, United States

Site Status

320 Johnson County Clin-Trials, 15602 College Blvd

Lenexa, Kansas, United States

Site Status

316 Heartland Research Associates LLC - Axtell Clinic - PA, 700 Medical Center Dr

Newton, Kansas, United States

Site Status

310 Heartland Research Associates LLC, 3730 N Ridge Road Suite 600

Wichita, Kansas, United States

Site Status

322 Heartland Research Associates Wichita, 1709 S. Rock Road

Wichita, Kansas, United States

Site Status

314 Saint Louis Univ Med Div of Infectious Diseases Immunology, 1100 S Grand Blvd DRC- Rm 827

St Louis, Missouri, United States

Site Status

330 Mercy Health Research, 12680 Olive Blvd Suite 200

St Louis, Missouri, United States

Site Status

313 Clinical Research Center of Nevada, 7425 W Azure Suite 150

Las Vegas, Nevada, United States

Site Status

311 Regional Clinical Research INC, 415 Hooper Road

Endwell, New York, United States

Site Status

326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104

Raleigh, North Carolina, United States

Site Status

332 Piedmont Medical Research, 1901 S. Hawthorne Rd. Suite 306

Winston-Salem, North Carolina, United States

Site Status

303 Prestige Clinical Research, 333 Conover Drive

Franklin, Ohio, United States

Site Status

325 Omega Medical Research, 400 Bald Hill Road

Warwick, Rhode Island, United States

Site Status

312 Spartanburg Regional Medical Center, 485 Simuel Road

Spartanburg, South Carolina, United States

Site Status

321 Jordan River Family Medicine, 1868 West 9800 South Ste 100

Jordan, Utah, United States

Site Status

317 J. Lewis Research Inc., 2295 Foothill Drive

Salt Lake City, Utah, United States

Site Status

305 Foothill Family Clinic South, 6360 South 3000 East

Salt Lake City, Utah, United States

Site Status

323 PI Coor Clinical Research LCC, 10721 Main St Suite 1500

Fairfax, Virginia, United States

Site Status

209, Centro de Investigacion CAFAM

Avenida Carrera 68, Bogota D.C., Colombia

Site Status

206, Centro de Atencion e Investigacion Medica CAIMED

Carrera 42A, Bogota D.C., Colombia

Site Status

213, Centro de Atencion e Investigacion Medica CAIMED

Carrera 42A, Bogota D.C., Colombia

Site Status

207, Centro de Investigacion Cafesalud Medicina Prepagada

Cra 14 No Piso Sexto, Bogota D.C., Colombia

Site Status

203, Health Research International HRI

Clayton Ciudad Del Saber Edificio 118, Provincia de Panamá, Panama

Site Status

205, Medical and Research Center Calle 53 Urbanizacion Marbella

Consultorios Royal Center 108, Provincia de Panamá, Panama

Site Status

103, De La Salle Health Sciences Institute

DBB B Dasmarinas, Cavite, Philippines

Site Status

102, De La Salle Health Sciences Institute

Dbbb Dasmarinas, Cavite, Philippines

Site Status

105, Manila Doctors Hospital, 667 United Nations Avenue

Ermita, Manila, Philippines

Site Status

106, Our Lady of Lourdes Hospital, 46 P. Sanchez Street Sta.

Mesa, Manila, Philippines

Site Status

104 Jose Reyes Memorial Medical Center

Rizal Avenue Avenida Cruz, Manila, Philippines

Site Status

107 Philippine General Hospital

Taft Avenue, Manila, Philippines

Site Status

101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest

Corporate City Alabang, Muntinlupa, Philippines

Site Status

109, Research Institute for Tropical Medicine Department of Health Compound FILINVEST

Corporate City Alabang, Muntinlupa, Philippines

Site Status

108, City Health Office 1 Rosa City

City Health Office 1, Rosa City, Philippines

Site Status

110, San Juan de Dios Hospital, 2772 Roxas Blvd

Pasay, , Philippines

Site Status

111, St Lukes Medical Center, 279 E Rodriguez Sr Boulevard

Quezon City, , Philippines

Site Status

Countries

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United States Colombia Panama Philippines

References

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Frey SE, Reyes MR, Reynales H, Bermal NN, Nicolay U, Narasimhan V, Forleo-Neto E, Arora AK. Comparison of the safety and immunogenicity of an MF59(R)-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014 Sep 3;32(39):5027-34. doi: 10.1016/j.vaccine.2014.07.013. Epub 2014 Jul 18.

Reference Type DERIVED
PMID: 25045825 (View on PubMed)

Other Identifiers

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V70_27

Identifier Type: -

Identifier Source: org_study_id

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