A Phase 3b, Randomized, Open-label, Multi-Center Study Assessing Immunogenicity, Safety and 1 Year Persistence of Antibodies after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Children 2 to 10 years of age.
- Conditions
- Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to healthy children 2 to 10 years of age.MedDRA version: 14.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-004421-27-HU
- Lead Sponsor
- ovartis Vaccines and Diagnostics s.r.l
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 715
Children from 2 to 10 years of age with up to date routine childhood vaccination (to the best knowledge of subjects’ parents/legal representatives), generally in good health, and available for all study visits, whose legally acceptable representative has given written informed consent at the time of enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with meningococcal any vaccine. Exposure within 60 days to individuals with culture proven meningococcal disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method