MenBvac vaccination efficiency
Phase 1
- Conditions
- Immunogenic Study, in french children living in the region of Normandy, France, after vaccination for B:14:P1.7,16, to evaluate the longer-term persistence of antibodies against B:14P1.7,16. bacterial strain.MedDRA version: 14.1Level: HLTClassification code 10027203Term: Meningeal bacterial infectionsSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2011-006209-83-FR
- Lead Sponsor
- CHU - Hôpitaux de Rouen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 218
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of French children living in the region of Normandy, France, after vaccination for B:14:P1.7,16, with hSBA level > 4, 2 years and 6 months after inoculation. ;Secondary Objective: none;Primary end point(s): hsBA level;Timepoint(s) of evaluation of this end point: january 2013, March 2012 and january 2013
- Secondary Outcome Measures
Name Time Method Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none