Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

1,357

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

October 31, 2010

Conditions
Influenza
Interventions
BIOLOGICAL

MF59-eH1N1

MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

Trial Locations (35)

14000

Instituto Nacional de Ciencias, Tlalpan

15025

Pediatric Physicians Research, Inc., Jefferson Hills

15220

Pediatric Alliance - Greentree Division (pediatrics), Pittsburgh

16125

UPMC/Community Medicine (pediatrics), Greenville

16506

Children's Health Care -West, Erie

22015

PI-Coor Clinical Research, Burke

23219

Virginia Commonwealth University, Richmond

27609

Capital Pediatrics and Adolescent Ctr., Raleigh

30062

Pediatrics and Adolescent Medicine, Marietta

30189

Pediatrics and Adolescent Medicine, Woodstock

37660

Holston Medical Group, Kingsport

40291

Bluegrass Clinical Research, Inc (Brownsboro for drug shipment), Louisville

44121

Dr. Senders and Associates, Pediatrics, Cleveland

45005

Prestige Clinical Research, Franklin

47150

Bluegrass Clinical Research, Inc., New Albany

60115

Northern Illinois Research Associates, DeKalb

67005

Heartland Research Associates LLC, Arkansas City

67114

Heartland Research Associates LLC, Newton

68134

Meridien Clinical Research, Omaha

73103

IPS Research, Oklahoma City

75234

Research Across America, Dallas

77055

West Houston Clinical Research Service, Houston

77375

Pediatric Healthcare of NW Houston, Tomball

80233

1st International Research Centers, Thornton

84109

J.Lewis Research, Inc./Foothill Family Clinic, Salt Lake City

84121

J. Lewis Research, Inc./Foothill Family Clinic South, Salt Lake City

89015

Clinical Research Center of Nevada, Henderson

90723

Center for Clincal Trials, LLC, Paramount

Center for Clinical Trials, LLC, Paramount

91790

Center for Clinical Trials of San Gabriel, West Covina

93637

Madera Family Medical Group, Madera

97006

The Portland Clinic LLP, Beaverton

99202

Rockwood Research Center, Spokane

90241-4982

Premier Health Research Center, LLC, Downey

02886

Omega Clinical Research, Warwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00972816 - Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years) | Biotech Hunter | Biotech Hunter