To assess the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers MedDRA version: 16.0 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: Nimenrix
Product Name: Nimenrix
Pharmaceutical Form: Powder and solvent for sol
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: 200 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. 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 enrollment 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 (Exceptions: 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) or tetanus toxoid (TT) 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 six months prior to 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 is considered as a contraindication to intramuscular injection. 12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature >= 38°C) within 3 days prior to enrollment. 13. Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reactogenicity of MenACWY-CRM and MenACWY-TT vaccines, given to healthy toddlers at 12-15 months of age, as measured by the percentage of subjects with at least one severe solicited AE reported between 6 hours and Day 7 post vaccination.;Secondary Objective: To assess the immunogenicity of one dose of MenACWY-CRM or MenACWY-TT, as measured by: 1) the % of subjects with hSBA titer =8, the percentage of subjects with seroresponse, and hSBA GMTs directed against N. meningitidis serogroups A, C, W and Y on Day 29 after vaccination and by 2) the % of subjects with rSBA titer =8, the percentage of subjects with rSBA titer = 128, four fold rise, and rSBA GMTs directed against N. meningitidis serogroups A, C, W and Y on Day 29 after vaccination; To assess the persistence of the immune response on Day 180 after vaccination with either one dose of MenACWY-CRM or MenACWY-TT, as measured by: 1) the % of subjects with hSBA titer =8, the percentage of subjects with seroresponse, and hSBA GMTs against N. meningitidis serogroups A, C, W and Y and by 2) the % of subjects with rSBA titer =8, the percentage of subjects with rSBA titer = 128, four fold rise, and rSBA GMTs directed against N. meningitidis serogroups A, C, W and Y. ;Primary end point(s): • Percentage of subjects with at least one severe solicited AE* within 7 days after vaccination (6 hours through Day 7) *Solicited AEs will include tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever. ;Timepoint(s) of evaluation of this end point: Day 7 after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 7, Day 29 and day 180 after vaccination;Secondary end point(s): Secondary immunogenicity endpoints: ? Percentage of subjects with hSBA titer =8 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination. ? Percentage of subjects with hSBA seroresponse against serogroups A, C, W and Y at Day 29 and Day 180 post vaccination, defined as: - for subjects with pre-vaccination hSBA titer <4, post vaccination hSBA titer =8; - for subjects with pre-vaccination hSBA titer =4, an increase of at least four times the pre vaccination hSBA. ? hSBA GMTs for serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination. ? Percentage of subjects with rSBA titer =8 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination. ? Percentage of subjects with rSBA titer = 128 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination. ? Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W and Y at Day 29 and Day 180 post vaccination. ? rSBA GMT for serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination. Secondary safety endpoints: ? Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination; ? Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) during the 7 days after vaccination; ? Unsolicited AEs reported from Day 1 to Day 29 after vaccination; ? Medically-attended AEs reported during the entire study period; ? AEs leading to premature withdrawal during the entire study period; ? SAEs reported during the entire study period. Secondary safety endpoints: ? Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination; ? Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) during the 7 days after vaccination; ? Unsolicited AEs reported from Day 1 to Day 29 after vaccina | — |
Countries
Italy
Contacts
Public ContactLaura Lulli
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed