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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00262028
First received: December 2, 2005
Last updated: January 31, 2008
Last verified: September 2006

December 2, 2005
January 31, 2008
April 2005
Not Provided
Immunogenicity as measured by serum bactericidal activity at one month following immunization
To compare the immunogenicity of a single dose of Chiron MenACWY Conjugate Vaccine with the immunogenicity of a single dose of licensed meningococcal ACWY polysaccharide vaccine (Menomune®), defined as percentage of subjects with serum bactericidal activ
Complete list of historical versions of study NCT00262028 on ClinicalTrials.gov Archive Site
Safety and tolerability of Chiron Meningococcal ACWY Vaccine
To assess the safety and tolerability of a single dose of either the adjuvanted or unadjuvanted formulation of Chiron MenACWY Conjugate Vaccine compared to the safety and tolerability of a single dose of Menomune®
Not Provided
Not Provided
 
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Prevention of Meningococcal Disease
Biological: Meningococcal Conjugate ACWY Vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
Not Provided

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
Both
12 Months to 10 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262028
V59P8
Not Provided
Not Provided
Novartis
Novartis Vaccines
Study Director: Drug Information Services Novartis Vaccines & Diagnostics
Novartis
September 2006

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