Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

PHASE3CompletedINTERVENTIONAL
Enrollment

662

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

July 31, 2009

Study Completion Date

October 31, 2010

Conditions
Meningococcal Meningitis
Interventions
BIOLOGICAL

MenACWY-CRM197 (two doses)

Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

BIOLOGICAL

MenC

One 0.5mL dose of MenC vaccine was administered by intramuscular injection.

BIOLOGICAL

PCV7

One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.

BIOLOGICAL

DTPa-IPV-HepB-Hib

One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.

BIOLOGICAL

MenACWY-CRM197 (one dose)

One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Trial Locations (28)

12589

Site 3, Berlin

12619

Site 27, Berlin

12627

Site 20, Berlin

Site 26, Berlin

13189

Site 13, Berlin

Site 31, Berlin

13347

Site 25, Berlin

22147

Site 35, Hamburg

24534

Site 21, Neumünster

Site 9, Neumünster

24937

Site 32, Flensburg

24960

Site 33, Glücksburg

37269

Site 39, Eschwege

55127

Site 28, Mainz

55131

Site 44, Mainz

55543

Site 22, Bad Kreuznach

58802

Site 24, Balve

67227

Site 16, Frankenthal

69168

Site 6, Wiesloch

70193

Site 4, Stuttgart

70469

Site 19, Stuttgart

71720

Site 10, Oberstenfeld

74357

Site 15, Bönnigheim

77694

Site 2, Kehl

81669

Site 43, München-Ramersdorf

82362

Site 30, Weilheim I OB

98724

Site 42, Neuhaus am Rennweg

07356

Site 38, Bad Lobenstein

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00667602 - Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers | Biotech Hunter | Biotech Hunter