Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitidis and septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals eligible to be enrolled in the study are those: 1. who are infants 6-month old inclusive, who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg; 2. who previously received three doses of both Prevenar (heptavalent conjugate pneumococcal) and Infanrix-hexa (DTaP-Hib-HBV-IPV) vaccines at least 30 days before study entry; 3. for whom a parent/legal representative has given written informed consent after the nature of the study has been explained; 4. who are available for all the visits scheduled in the study; 5. who are in good health as determined by: a) medical history b) physical assessment c) clinical judgment of the investigator 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: Individuals not eligible to be enrolled are those: - whose parent/legal representative is unwilling or unable to give written informed consent to participate in the study; - who previously received any meningococcal vaccine; - who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period longer than or equal to 2 weeks associated with apnea or whooping); - who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component (including latex allergy); - who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature = 38.0°C) within the previous 3 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase 3 study is to demonstrate the safety and immune response of MenACWY compared to Menjugate when administered to healthy toddlers at 12 months of age. Subjects will receive Infanrix-hexa and Prevenar at 12 months of age;Secondary Objective: - assess and compare immunogenicity of one dose of MenACWY to one dose of Menjugate in healthy toddlers at 12 months of age as measured by hSBA GMTs and percentage of subjects with hSBA-titers = 1:4, directed against N. meningitidis serogroup C; - assess immunogenicity of one dose of MenACWY in toddlers at 12 months of age as measured by the percentage of subjects with hSBA-titers = 1:8, the percentage of subjects with hSBA-titers = 1:4 and hSBA GMTs directed against N. meningitidis serogroups A, W and Y; - assess and compare immunogenicity of two doses of MenACWY in infants at 6 and 12 months of age to a single dose of Menjugate in toddlers at 12 months of age as measured by hSBA GMTs, percentage of subjects with hSBA-titers = 1:8 and hSBA-titers = 1:4, directed against N. meningitidis serogroup C; ;Primary end point(s): The primary criteria for immunogenicity is that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY and Menjugate in the percentage of subjects with hSBA-titers = 1:8 for serogroup C at 1 month following vaccination at 12 months is greater than -10% | — |
Countries
Germany
Outcome results
None listed