Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years 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 Disease
Intervention: Meningococcal ACWY conjugate vaccine (Vaccine)
Phase: Phase 3
Status: Recruiting. Expecting to enroll 1500 people.
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Vaccines - Drug Information Services, Study Chair, Affiliation: Novartis Vaccines & Diagnostics
Overall contact:
Novartis Vaccines - Drug Informtion Services, Phone: +1 800 244 7668, Ext: press 2
Summary
Safety and immunogenicity of Meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age
Clinical Details
Official title:
A Phase III, Randomized, Observer Blind Multi-Center Study to Compare the Safety of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age
Study design: Interventional, Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Secondary outcome:
Eligibility
Minimum age: 2 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy children 2 to 10 years of age inclusive
Exclusion Criteria:
- Previous or suspected disease caused by N. meningitidis Previous vaccination with a meningitis vaccine
- Any household contact with an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment
- Any auto-immune disease or other serious acute, chronic or progressive disease.
Locations and Contacts
Novartis Vaccines - Drug Informtion Services, Phone: +1 800 244 7668, Ext: press 2
Hospital de Pediatria "Sor Maria Ludovica", Calle 14, N°1632, La Plata, Argentina; Recruiting
Centro di Desarrollo de Projectos Avanzados (CEDEPAP) Roma 1465, Cordoba, Argentina; Recruiting
FUNCEI, French 3085, Buenos Aires, Argentina; Recruiting
Additional Information
Starting date:
May 2006
Last updated: September 13, 2006
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