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: Participants eligible to be enrolled in the follow-on study are those who: 1. have completed the V59P5 study; 2. are healthy children age 40 months inclusive (+84 days) (Visit 7) or 60 months (+84 days) (Visit 8); 3. are children in good health as determined by: - medical history; - physical assessment; - clinical judgment of the investigator; 4. children whose parent(s) give written informed consent for their child to be enrolled in the 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: Participants who are not eligible for the follow up study are those: 1. whose parents have not given or are unwilling or unable to give written informed consent for their child’s participation in the study; 2. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): a. receipt of immunosuppressive therapy within the past 30 days (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1mg/kg/day prednisone or equivalent during any of the previous 30 days, or cancer chemotherapy); b. receipt of immunostimulants; c. receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within the past 90 days and for the full length of the study; 3. who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis serogroup A, C, W, or Y infection within 60 days prior to enrollment; 4. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature = 38°C) within 3 days prior to enrollment; 5. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome; 6. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any study vaccine component (including latex allergy); 7. who have any serious acute, chronic or progressive disease such as a. history of cancer (excluding minor non-melanoma skin cancer) b. diabetes mellitus c. arteriosclerotic disease d. autoimmune disease e. HIV infection or AIDS f. blood dyscrasias g. congestive heart failure h. renal failure i. severe malnutrition 8. who have a condition that is a contraindication to vaccination; 9. who are participating in any other clinical trial either currently or in the previous 90 days prior to enrolment; 10. who are unable to adhere to the protocol; 11. who have a condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY- at 2, 4 and 12 months of age, in terms of percentage of participants with human SBA (hSBA) titers = 1:8 for each of meningococcal serogroups A, C, W-135 and Y (Men A, C, W, Y).;Secondary Objective: - To evaluate the persistence of immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY- at 2, 4 and 12 months of age, in terms of percentage of participants with hSBA titers = 1:4 and hSBA geometric mean titers (GMTs) for each of Men A, C, W, Y. - To evaluate the immunity against meningococcal serogroups A, C, W-135, Y at 60 months of age in age-matched children, who have received the site-specific primary immunization schedule in terms of percentage of participants with hSBA titers = 1:4 and GMTs for each of Men A, C, W-135, and Y. - To evaluate the immunity against Men A, C, W-135, Y at 40 and 60 months of age in children who were vaccinated with MenACWY+ at age 2, 4 and 12 months, as measured by percentage of subjects with hSBA titer = 1:4, percentage of subjects with hSBA titer = 1:8 and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y.;Primary end point(s): The anti-N. meningitidis serogroup A, C, W-135 and Y bactericidal activity titers will be measured by hSBA. These results will be expressed as GMT and percentage of subjects with hSBA = 1:4 and hSBA = 1:8. | — |
Countries
United Kingdom
Outcome results
None listed