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

PHASE3CompletedINTERVENTIONAL
Enrollment

7,109

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

August 31, 2011

Study Completion Date

November 30, 2011

Conditions
Influenza
Interventions
BIOLOGICAL

MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)

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

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

Trial Locations (38)

1000

105, Manila Doctors Hospital, 667 United Nations Avenue, Ermita

107 Philippine General Hospital, Taft Avenue

1003

104 Jose Reyes Memorial Medical Center, Rizal Avenue Avenida Cruz

1016

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

1102

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

1300

110, San Juan de Dios Hospital, 2772 Roxas Blvd, Pasay

1750

206, Centro de Atencion e Investigacion Medica CAIMED, Carrera 42A

213, Centro de Atencion e Investigacion Medica CAIMED, Carrera 42A

1781

101, Asian Hospital and Medical Center 2205 Civic Drive Filinvest, Corporate City Alabang

4026

108, City Health Office 1 Rosa City, City Health Office 1

4114

103, De La Salle Health Sciences Institute, DBB B Dasmarinas

102, De La Salle Health Sciences Institute, Dbbb Dasmarinas

13760

311 Regional Clinical Research INC, 415 Hooper Road, Endwell

22030

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

27103

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

27612

326 Triangle Medical Research, 5816 Creedmoor Rd. Suite 104, Raleigh

29303

312 Spartanburg Regional Medical Center, 485 Simuel Road, Spartanburg

32205

306 Westside Center for Clinical Research, 810 Lane Avenue South, Jacksonville

32720

318 Avail Clinical Research, 860 Peachwood Drive, DeLand

33143

328 Miami Research Associates, 6141 Sunset Drive, Miami

45005

303 Prestige Clinical Research, 333 Conover Drive, Franklin

63104

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

63141

330 Mercy Health Research, 12680 Olive Blvd Suite 200, St Louis

66219

320 Johnson County Clin-Trials, 15602 College Blvd, Lenexa

67114

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

67205

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

67207

322 Heartland Research Associates Wichita, 1709 S. Rock Road, Wichita

84109

317 J. Lewis Research Inc., 2295 Foothill Drive, Salt Lake City

84121

305 Foothill Family Clinic South, 6360 South 3000 East, Salt Lake City

85253

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

89130

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

02886

325 Omega Medical Research, 400 Bald Hill Road, Warwick

Unknown

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

209, Centro de Investigacion CAFAM, Avenida Carrera 68

207, Centro de Investigacion Cafesalud Medicina Prepagada, Cra 14 No Piso Sexto

203, Health Research International HRI, Clayton Ciudad Del Saber Edificio 118

205, Medical and Research Center Calle 53 Urbanizacion Marbella, Consultorios Royal Center 108

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY