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

Tracking Information

First Received Date ^ICMJE

May 23, 2006

Last Updated Date

April 16, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00329849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningococcal Disease

Intervention ^ICMJE

Biological: Meningococcal ACWY conjugate vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1500

Completion Date

Primary Completion Date

May 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy children 2 to 10 years of age inclusive

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.

Gender

Both

Ages

2 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina

Administrative Information

NCT ID ^ICMJE

NCT00329849

Responsible Party

Study ID Numbers ^ICMJE

V59P10

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

Information Provided By

Novartis

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP