The primary objective of this phase 3b study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. MedDRA version: 12.1 Level: LLT Classification code 10027202 Term: Meningitis bacterial
Conditions
Interventions
Trade Name: Menveo
Product Name: Novartis MenACWY Conjugate Vaccine
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: MenA-CRM
Concentration unit: µg microgram
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators. Subjects must be 22-45 months of age at the time of enrollment into V59P22E1 and have participated in the original V59P22 study. Are the trial subjects under 18? yes Number of subjects for this age range: 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: Serious, acute, or chronic illnesses are reasons for exclusion. Non-standard exclusion criteria include the following: ? Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines are excluded for the 14 days prior to the enrollment visit. ? Subjects who have received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To assess the safety and tolerability of a dose of MenACWY in subjects who were previously vaccinated with one or two doses of MenACWY or MenC. Co-primary: 1.To evaluate the persistence of the antibody response in children previously vaccinated with one or two doses of MenACWY or MenC in study V59P22, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers = 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y. 2.To evaluate the antibody response to a booster dose of MenACWY in children previously vaccinated with one or two doses of MenACWY as measured by of percentage of subjects with hSBA titers = 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, Y. 3.To evaluate the antibody response to one dose of MenACWY in children previously vaccinated with MenC as measured by of percentage of subjects with hSBA titers = 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, Y.;Secondary Objective: Secondary 1. To evaluate the persistence of the antibody response in children previously vaccinated with one or two doses of MenACWY or MenC in study V59P22, as measured by hSBA geometric mean titers (GMTs) directed against N. meningitidis serogroups A, C, W-135, and Y. 2. To compare the antibody response to one dose of MenACWY in children previously vaccinated with MenACWY and in children previously vaccinated with MenC as measured by percentage of subjects with hSBA titers = 1:8, and hSBA GMTs directed against N. meningitidis serogroups A, C W-135, Y.;Primary end point(s): Immunogenicity Endpoints At all time points, in all subjects the following will be evaluated: 1. Percentage of subject with hSBA titers = 1:8 2. hSBA geometric mean titers (GMTs), N. meningitidis serogroups A, C, W-135 and Y The persistence is defined as a function of time, from the last vaccination, of the serogroup specific hSBA titers. Safety Endpoints ? The percentage of subjects with solic | — |
Countries
Germany
Outcome results
None listed