NCT00316654CompletedPhase 4
A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule
Novartis Vaccines2 sites in 2 countries489 target enrollmentStarted: February 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 489
- Locations
- 2
- Primary Endpoint
- Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Study Overview
Brief Summary
Persistence of Antibody Response to N. meningitidis Group C in Children
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy children
Exclusion Criteria
- •previous ascertained or suspected disease caused by N. meningitidis
- •previous significant acute or chronic infections
- •any other serious disease
Outcomes
Primary Outcomes
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA
Secondary Outcomes
- Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
- safety and tolerability
Investigators
Study Sites (2)
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