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

This study has been completed.

First Received on May 23, 2006. Last Updated on April 16, 2008 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00329849

Purpose

Safety and immunogenicity of Meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Condition	Intervention	Phase
Meningococcal Disease	Biological: Meningococcal ACWY conjugate vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Phase III, Randomized, Observer Blind Multi-Center Study to Compare the Safety of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Meningococcal Infections

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Comparison of percentage of subjects presenting at least one severe systemic reaction to the study vaccines during the first 7 days following immunization.

Secondary Outcome Measures:

Comparison of the immunogenicity as percentage of subjects with human Serum Bactericidal Assay (hSBA) ³ 1:8 against N. meningitidis at 1 month after vaccination.
Comparison of the immunogenicity as: (1) percentage of subjects with hSBA ³1:4 and (2) hSBA geometric mean titers (GMTs) against N. meningitidis, at 1 month after vaccination.
Comparison of the immunogenicity as: (1) percentage of subjects with hSBA ³1:8, (2) percentage of subjects with hSBA ³1:4 and (3) hSBA GMTs against N. meningitidis at day 181 after vaccination.

Estimated Enrollment:	1500
Study Start Date:	May 2006
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Previous or suspected disease caused by N. meningitidis Previous vaccination with a meningitis vaccine
Any household contact with an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment
Any auto-immune disease or other serious acute, chronic or progressive disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329849

Locations

Argentina
FUNCEI, French 3085
Buenos Aires, Argentina
Centro di Desarrollo de Projectos Avanzados (CEDEPAP) Roma 1465
Cordoba, Argentina
Hospital de Pediatria "Sor Maria Ludovica", Calle 14, N°1632
La Plata, Argentina

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00329849 History of Changes
Other Study ID Numbers:	V59P10
Study First Received:	May 23, 2006
Last Updated:	April 16, 2008
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Meningitis
children
vaccine
safety
efficacy

Additional relevant MeSH terms:

Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012