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: 14.0 Level: PT Classification code 10027202 Term: Meningitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Menveo
Product Name: Menveo
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
Novartis Vaccines and Diagnostics s.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): All immunogenicity endpoints refer to each N. meningitidis serogroups A, C, W, Y. Primary: Percentage of subjects with hSBA seroresponse, defined as: • for subjects with pre-vaccination hSBA <1:4, post vaccination hSBA =1:8 • for subjects with pre-vaccination hSBA =1:4, an increase of at least four times of the pre-vaccination hSBA. • Safety will be assessed for all subjects in terms of the frequency and percentage of reported adverse events (AEs), medically attended AEs and serious adverse events (SAEs). - All AEs will be collected for 7 days following each administration of the study vaccine. - Medically attended AEs, AEs resulting in premature withdrawal from the study and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation. ;Main Objective: Immunogenicity objectives: Primary 1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 2 to 5 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination. 2. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 6 to 10 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination. Safety objectives: •All adverse events (AEs) reported during days 1 to 7 after each vaccination; •All medically attended AEs reported from study day 1 to study termination/early termination; •All Serious adverse events (SAEs) reported from study day 1 to study ;Secondary Objective: Immunogenicity objectives: Secondary 1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children in two age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: • Percentage of subjects with hSBA =1:8. • hSBA GMTs. Safety Endpoints ;Timepoint(s) of evaluation of this end point: one month and one year after last vaccination | — |
Countries
Hungary
Contacts
Public ContactInformation Desk
Novartis Vaccines and Diagnostics
Outcome results
None listed