Prevention of meningococcal disease caused by serogroup C Neisseria meningitidis by evaluating the immunogenicity, tolerability, and safety of a liquid formulation of Novartis meningococcal C conjugate vaccine (MenC-CRM liquid) and of the lyophilized MenC-CRM vaccine produced with drug substance manufactured at Rosia, Italy, in comparison to the lyophilized MenC-CRM vaccine produced with drug substance manufactured at Emeryville, USA (Menjugate Kit). MedDRA version: 15.0 Level: LLT Classificati
Conditions
Interventions
Product Name: Meningococcal C-CRM conjugated vaccine
Product Code: MenC-CRM ROS
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Neisseria meningitidis group C
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible to be enrolled in the study: 1. Healthy 12 – 23 (inclusive) month-old male or female toddlers 2. A parent/legal guardian has given written informed consent after the nature of the study has been explained. 3. Available for both the visits scheduled in the study. 4. In good health as determined by medical history, physical examination and clinical judgment of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 979 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. History of any meningococcal vaccine administration. 2. Previous known or suspected disease caused by N. meningitidis. 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization. 4. History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine. 5. Significant acute or chronic infection within the previous 7 days or axillary temperature =38.0°C within the previous 3 days. 6. Individuals who have received antibiotics within 6 days before vaccination. . 7. Known or suspected autoimmune disease or impairment/alteration of the immune system 8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable). 9. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 11. Taken any antipyretic medication in the previous 6 hours. 12. Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization). 13. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 14. Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study. 15. Family members or household members of site research staff. 16. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 17. Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The equivalence of MenC-CRM liquid to Menjugate Kit and the equivalence of MenC-CRM ROS to Menjugate Kit will be simultaneously assessed with adjustment for multiple comparisons. 1. To demonstrate the equivalence of MenC-CRM liquid to Menjugate Kit when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N. meningitidis type C, approximately 28 days after a single vaccination. 2. To demonstrate the equivalence of MenC-CRM ROS to Menjugate Kit when administered to toddlers, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against N. meningitidis type C, approximately 28 days after a single vaccination. ;Secondary Objective: To demonstrate equivalence of MenC-CRM liquid to MenC-CRM ROS when administered to toddlers, as measured by the ratio of the hSBA GMTs, approximately 28 days after a single vaccination.;Primary end point(s): ? hSBA GMTs against serogroup C at day 29 for the MenC-CRM liquid and MenC-CRM EMV vaccine groups. ? hSBA GMTs against serogroup C at day 29 for the MenC-CRM ROS and MenC-CRM EMV vaccine groups. ;Timepoint(s) of evaluation of this end point: 28 days after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? hSBA GMTs against serogroup C at day 29 for the MenC-CRM liquid and MenC-CRM ROS vaccine groups. ;Timepoint(s) of evaluation of this end point: 28 days after vaccination | — |
Countries
Poland
Contacts
Public ContactDaniela Burroni
Novartis Vaccines and Diagnostics S.r.l.
Outcome results
None listed