Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

PHASE3CompletedINTERVENTIONAL
Enrollment

2,907

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

April 30, 2009

Study Completion Date

October 31, 2009

Conditions
Meningococcal Infections
Interventions
BIOLOGICAL

MenACWY-CRM

1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly

BIOLOGICAL

MenACWY-CRM

2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age

BIOLOGICAL

Licensed meningococcal ACWY vaccine

1 injection of the licensed meningococcal ACWY was administered intramuscularly

Trial Locations (68)

14618

Legacy Pediatrics, Rochester

15090

Children's Community Pediatrics, Wexford

15217

Pediatric Alliance PC, Pittsburgh

15220

Pediatric Alliance PC, Pittsburgh

15227

South Hills Pediatrics, Pittsburgh

15236

Pediatric Alliance PC, Pittsburgh

15237

Primary Physicians Research Inc., Pittsburgh

15241

Primary Physicians Research Inc., Pittsburgh

Family Practice Medical Associates South, Upper Saint Clair

15401

Laurel Pediatrics, Uniontown

15650

Pediatric Associates of Latrobe, Latrobe

16125

University Of Pittsburgh Medical Center, Greenville

16127

Family Healthcare Partners, Grove City

16505

Children's Health Care - West, Erie

27704

Duke University Medical Center, Durham

Durham Pediatrics, Durham

Regional Pediatric Associates PA, Durham

38305

Jackson Clinic Professional Association, Jackson

40004

Kentucky Pediatric Research Center, Bardstown

Physicians to Children & Adolescents, Springfield

44121

Dr. Senders and Associates, Cleveland

58103

Odyssey Research, Fargo

63104

St. Louis University School of Medicine, St Louis

68134

Meridian Clinical Research LLC, Omaha

70006

Benchmark Research, Metairie

72205

Arkansas Pediatric Research Group, Little Rock

72712

Children's Investigational Reserach Program, Bentonville

76135

Benchmark Research Ft. Worth, Fort Worth

76904

Benchmark Research San Angelo, San Angelo

80012

Kaiser Permanente - Aurora, Aurora

80112

1st Allergy & Clinical Research, Centennial

80233

1st Allergy & Clinical Research, Thornton

80234

Kaiser Permanente - Westminister, Westminister

80501

Longmont Medical Research Network, Longmont

84015

Jean Brown Research, Clinton

84041

Wee Care Pediatrics, Layton

84095

Copperview Medical Center, South Jordan

84107

Cottonwood Pediatrics, Murray

84109

J. Lewis Research Inc., Salt Lake City

84121

J. Lewis Research Inc., Salt Lake City

84124

Jean Brown Research, Salt Lake City

90241

Premier Health Research Center, Downey

93726

Kaiser Permanente - Fresno, Fresno

94115

Kaiser Permanente - San Francisco, San Francisco

94538

Kaiser Permanente - Fremont, Fremont

94545

Kaiser Permanente - Hayward, Hayward

94566

Kaiser Permanente - Pleasanton, Pleasanton

94611

Kaiser Permanente - Oakland, Oakland

95119

Kaiser Permanente - San Jose, San Jose

97030

Calcagno Research & Development, Gresham

99202

Rockwood Clinic, Spokane

99218

Rockwood Clinic North, Spokane

V3R 8P8

TASC Research Services Inc., Surrey

R3A 1M3

Manitoba Clinic, Winnipeg

B3K 6R8

Clinical Trials Research Center, Halifax

B2N 1L2

Colchester Regional Hospital, Truro

M9V 4B4

Albion Finch Medical Centre, Etobicoke

P3E 1H5

Medicor Research Inc., Greater Sudbury

N6A 1V2

Children's Hospital of Western Ontario, London

L3Y 5G8

SKDS Research In., Newmarket

K1S 0G8

Herridge Community Health Clinic, Ottawa

N7T 4X3

Sarnia Institute of Clinical Research, Sarnia

M5G 1N8

Resolve Research Solutions, Toronto

M5M 1B2

Resolve Research Solutions, Toronto

C1A 8T5

Queen Elizabeth Hospital, Charlottetown

S7N 0W8

Royal University Hospital, Saskatoon

A1N 1W7

Commonwealth Medical Clinic, Mount Pearl

A1A 3R5

White Hills Medical Clinic, St. John's

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY