Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W) MedDRA version: 19.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1) Aged 12 to 23 months on the day of the first study visit 2) Subjects have received all recommended standard-of-care nonmeningococcal vaccinations according to his/her age as per local regulations. 3) Informed consent form (ICF) has been signed and dated by the parent/legally acceptable representative 4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures 5) Covered by health insurance if required by local regulations 6) Subjects have not received any meningococcal vaccine in the second year of life (i.e., from 12 months of age). 7) For Inclusion in Groups 1 and 2: Subjects must not have received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine). 8) For Inclusion in Groups 3 and 4:Subjects must have previously received at least 1 dose of licensed monovalent meningococcal C conjugate (MenC) vaccine during infancy (i.e., before 12 months of age) Are the trial subjects under 18? yes Number of subjects for this age range: 918 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: An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1) Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure 2) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines 3) Receipt of immune globulins, blood or blood-derived products in the past 3 months 4) For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine) 5) For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C conjugate (MenC) vaccination received during infancy 6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 7) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically 8) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) 9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances 10) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine 11) Personal history of Guillain-Barré syndrome (GBS) 12) Verbal report of thrombocytopenia as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination in the Investigator’s opinion 13) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion 14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. 16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw 17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy 2) To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers;Secondary Objective: 1) To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy 2) To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers 3) To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy;Primary end point(s): 1) Antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W measured by serum bactericidal assay using human complement (hSBA) assessed at 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy 2) Antibody titers.= 1:8 against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers;Timepoint(s) of evaluation of this end point: 30 days (+14 days) after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenCvaccination during infancy 2) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers 3) GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA before and 30 days (+14 days) after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who received monovalent MenC vaccination during infancy;Timepoint(s) of evaluation of this end point: 30 days (+14 days) after vaccination | — |
Countries
Finland, Germany, Hungary, Spain
Contacts
Public ContactUnidad de Estudios Clínicos
sanofi-aventis, s.a.
Outcome results
None listed