To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers, as measured by the percentage of subjects with serum bactericidal assay using human complement (hSBA) titers =8 against N. meningitidis serogroup C, at 28 days after the vaccination. MedDRA version: 14.1 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
Trade Name: Meningitec
Product Name: Meningitec
Pharmaceutical Form: Suspension for injecti
Sponsors
Novartis Vaccines and Diagnostics s.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Male and female children between 12 months and 15 months old inclusive (minimum 365 days of age and maximum 15 months plus 29 days of age), who were born with an estimated gestational age = 37 weeks; 2. For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements; 3. Who the investigator believes that their parents/ guardians will be available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls); 4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; Are the trial subjects under 18? yes Number of subjects for this age range: 1000 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: described. 1. Subjects that had a previous confirmed or suspected disease caused by N. meningitidis. 2. Who were previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease. 3. Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 4. Who have received within 90 days prior to enrolment or are expected to receive during the study period any investigational or non-registered product (drug or vaccine). 5. Who have received or who are planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exception: Injectable influenza vaccine may be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination). 6. Who have a major congenital defect or a serious chronic disease. 7. Who have a history of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) and latex. 8. Who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed). 9. Who received immunoglobulins and/or any blood products within 90 days prior study vaccination or who have administration planned during the study period. 10. Who have any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 11. Who have any bleeding disorder which consider as a contraindication to intramuscular injection or blood draw. 12. Who have experienced a significant acute infection or fever (defined as temperature = 38°C) within 3 days prior enrolment. 13. Who have received systemic antibiotic treatment within 7 days prior to enrolment. There may be instances when individuals meet all entry criteria except one that relates to transient clinical circumstances (e.g., body temperature elevation or recent use of excluded medication or vaccine). Under these circumstances, a subject may be considered eligible for study enrollment if the appropriate window for delay has passed, inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity objectives 1.To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers, as measured by the percentage of subjects with serum bactericidal assay using human complement (hSBA) titers =8 against N. meningitidis serogroup C, at 28 days after the vaccination. Safety objectives: 1. To assess the safety and reactogenicity of MenACWY and MenC vaccines.;Secondary Objective: 1 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with hSBA titers =8 against N.meningitidis serogr. A, W and Y, at 28 days post vacc. 2 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by the % of subj. with hSBA seroresponse against N.meningitidis serogr. C, at 28 days post vacc. 3 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by hSBA geometric mean titers (GMTs) against N.meningitidis serogr. C, at 28 days post vacc. 4 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with seroresponse and by hSBA GMTs against N.meningitidis serogr. A, W and Y, at 28 days post vacc. 5 Assess immunogenicity of 1 dose of MenACWY and 1 dose of MenC, as measured by the % of subj. with serum bactericidal assay using rabbit complement rSBA titers=8, the % of subj. with rSBA titers=128 and by rSBA GMTs against N.meningitidis serogr. A,C,W,Y at 28 days post vacc. (in subset of subj.);Primary end point(s): Primary Immunogenicity Endpoint - Percentage of subjects with hSBA =1:8 against serogroup C at Day 30 post vaccination. Safety Endpoints Safety data will be summarized by vaccination group: - Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination;Timepoint(s) of evaluation of this end point: Primary Immunogenicity Endpoint - Percentage of subjects with hSBA =1:8 against serogroup C at Day 30 post vaccination. Safety Endpoints Safety data will be summarized by vaccination group: - Solicited loca | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of subjects with hSBA titers =8 against serogroups A, W and Y at Day 29 post vaccination. - Percentage of subjects with hSBA seroresponse[1] against serogroups A, C, W and Y at Day 29 post vaccination. - hSBA GMTs for serogroups A, C, W and Y at Day 29 post vaccination. - Percentage of subjects with rSBA titer =8 against serogroups A, C, W and Y at Day 29 post vaccination. - Percentage of subjects with rSBA titers =128 against serogroups A, C, W and Y at Day 29 post vaccination. - rSBA GMT for serogroups A, C, W and Y at Day 29 post vaccination.;Timepoint(s) of evaluation of this end point: - Percentage of subjects with hSBA titers =8 against serogroups A, W and Y at Day 29 post vaccination. - Percentage of subjects with hSBA seroresponse[1] against serogroups A, C, W and Y at Day 29 post vaccination. - hSBA GMTs for serogroups A, C, W and Y at Day 29 post vaccination. - Percentage of subjects with rSBA titer =8 against serogroups A, C, W and Y at Day 29 post vaccination. - Percentage of subjects with rSBA titers =128 against serogroups A, C, W and Y at Day 29 post vaccination. - rSBA GMT for serogroups A, C, W and Y at Day 29 post vaccination. | — |
Countries
Italy
Contacts
Public ContactLaura Lulli
Novartis Vaccines and Diagnostics s.r.l.
Outcome results
None listed