Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00262028

Purpose

The purpose of this study is to evaluate the safety and immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Condition	Intervention	Phase
Prevention of Meningococcal Disease	Biological: Meningococcal Conjugate ACWY Vaccine	Phase II

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Single-Blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-Label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity at one month following immunization

Secondary Outcome Measures:

Safety and tolerability of Chiron Meningococcal ACWY Vaccine

Estimated Enrollment:	1000
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	12 Months to 10 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Group 1: Healthy children 2-10 years of age;
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Exclusion Criteria:

Group 1: Subjects with a previous or suspected disease caused by N meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
Group 2: Subjects with a previous or suspected disease caused by N meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262028

Locations

United States, California

Oakland, California, United States, 94612

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Director:

Drug Information Services

Novartis Vaccines & Diagnostics

More Information

Study ID Numbers:	V59P8
Study First Received:	December 2, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00262028
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Healthy

Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009