The Novartis Meningococcal A, C, W-135 and Y Vaccine is intended for prevention of meningitidis and/or septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
Conditions
Interventions
Product Name: Novartis Meningococcal ACWY Conjugate Vaccine
Product Code: V59
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
Novartis Vaccines and Diagnostics S.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.healthy infants aged 2 months (56 – 83 days old, inclusive) 2.available for the visits scheduled in the study; 3.mother available for blood draw at Visit 1; 4.in good health as determined by: -medical history -clinical judgment of the investigator -pre-vaccination check performed by a physician; 5.whose parents can give written informed consent for the infant to be enrolled in the study. The infant’s parents must be willing for the infant to receive the full primary immunization course 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: 1. Whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study 2. With known hypersensitivity to any vaccines contained within the routine immunization schedule 3. With unacceptable concurrent illnesses or conditions – e.g.: a. a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; b. a genetic anomaly, e.g. Down’s syndrome; c. any immunodeficiency, including use of systemic corticosteroids; d. born at less than 36 weeks gestation; e. weighing less than 2.5 kg at birth; f. previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease; g.known bleeding diathesis, or any condition associated with a prolonged bleeding time; 4. Who have received any prohibited prior or concomitant medications - e.g.: a. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B; b. immunoglobulin; c. any blood products; 5. Participating in any other clinical trial either currently or in the previous month; 6. Unable to adhere to the protocol, including plans to move from the area; 7. Other: With any 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 assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age To evaluate the safety and tolerability of Novartis MenACWY vaccine when given at 2 and 4 months of age concomitantly with a combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine (DTaP-Hib-IPV, Pediacel®) and a heptavalent PCV (Prevenar®) To evaluate the safety and tolerability of Novartis MenACWY vaccine when given with or without concomitant PCV at 12 months of age ; Secondary Objective: To assess whether the frequency of Men ACWY serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month course of MenACWY vaccine, predicts: -The concentration of (respectively) serogroup A, C, W-135 and Y specific IgG and memory B-cells at 12 months of age. -(respectively) serogroup A, C, W-135 and Y specific memory B-cells and IgG concentrations and hSBA titers 1 month after a booster dose of MenACWY administered at 12 months of age. -the rise from pre-booster levels in (respectively) serogroup A, C, W-135 and Y specific IgG, and memory B-cell concentration and hSBA titers 1 month after a booster dose of MenACWY administered at 12 months of age -the concentration of (respectively) serogroup A, C, W-135 and Y specific plasma cells and memory B-cells and specific IgG and hSBA titers in the week following a booster dose of MenACWY administered at 12 months of age. ;Primary end point(s): To assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a 2, 4-month cour | — |
Countries
United Kingdom
Outcome results
None listed