Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants - Tabular View

Tracking Information

First Received Date ^ICMJE

December 2, 2005

Last Updated Date

April 16, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Immunogenicity as measured by serum bactericidal activity at one month following 3rd vaccination

Original Primary Outcome Measures ^ICMJE

To assess the immunogenicity of two or three doses of Chiron MenACWY conjugate vaccine given at 2, 3, 4 or 2, 4, 6 months of age, as measured by the percentage of subjects with serum bactericidal activity against N. meningitidis serogroups A, C, W and Y

Change History

Complete list of historical versions of study NCT00262002 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immune response following 2nd immunization and memory response at 12 months of age; Safety and tolerability

Original Secondary Outcome Measures ^ICMJE

To evaluate the safety and tolerability of Chiron MenACWY conjugate vaccine when given concomitantly with other licensed pediatric vaccines at 2, 3, 4 or 2, 4, 6 months of age

Descriptive Information

Brief Title ^ICMJE

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Official Title ^ICMJE

A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

Brief Summary

The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Chiron Meningococcal ACWY Conjugate Vaccine administered to healthy infants.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prevention of Meningococcal Disease

Intervention ^ICMJE

Biological: Meningococcal Conjugate ACWY 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

600

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy 2-month old infants born after full-term pregnancy

Exclusion Criteria:

Subjects who previously received any meningococcal vaccine; Subjects with any serious, acute or chronic progressive disease.

Gender

Both

Ages

55 Days to 89 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00262002

Responsible Party

Study ID Numbers ^ICMJE

V59P5, 2004-000195-13

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Director:

Novartis Vaccines

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