Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Information source: Novartis
Information obtained from ClinicalTrials.gov on 2006-11-30
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningococcal Infection
Intervention: Meningococcal C conjugate vaccine (Vaccine)
Phase: Phase 4
Status: Completed. Expecting to enroll 241 people.
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Vaccines - Information Services, Principal Investigator, Affiliation: Novartis Vaccines & Diagnostics
Summary
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Clinical Details
Official title:
A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age
Study design: Interventional, Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Secondary outcome:
Eligibility
Minimum age: 32 Months.
Maximum age: 40 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy children
Exclusion Criteria:
- known hypersensitivity to any vaccine component
- significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
- ascertained or suspected disease caused by N. meningitidis
- household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
Locations and Contacts
Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,, Oppenheim,, Kempten, Germany
Additional Information
Starting date:
June 2005
Last updated: October 25, 2006
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