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: 14.1 Level: HLT Classification code 10027203 Term: Meningeal bacterial infections System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: MenBvac(R)
Product Code: 9053
Pharmaceutical Form: Concentrate and solvent for solution for injection
Sponsors
CHU - Hôpitaux de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
Public Contactclinical research associate
CHU - Hôpitaux de Rouen
Outcome results
None listed