Status:
COMPLETED
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Lead Sponsor:
Novartis Vaccines
Conditions:
Prevention of Meningococcal Disease
Eligibility:
All Genders
12-10 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT00262028
Start Date
April 1 2005
End Date
November 1 2006
Last Update
February 11 2016
Active Locations (1)
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1
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94612