Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

Meningococcal ACWY-CRM conjugate vaccine

MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.

BIOLOGICAL

Meningococcal ACWY-PS polysaccharide vaccine

MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

Trial Locations (3)

Unknown

FUNCEI, French 3085, Buenos Aires

Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464, Córdoba

"Hospital de Pediatria Sor Maria Ludovica, Calle 14 N1631,(1900)", La Plata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY