Healthy meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54
Conditions
Interventions
Product Name: MenACYW Conjugate Vaccine
Product Code: 395
Pharmaceutical Form: Solution for solution for injection
INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETA
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) Participated in and completed (attended Visit 2) study MET54 2) Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations) 3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures Are the trial subjects under 18? yes Number of subjects for this age range: 188 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 a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the subject is due to receive vaccination(s) recommended for his / her age by the national immunization schedule at the time of the study, the subject will be recommended to complete his/her immunization schedule after Visit 2. 3) Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54 4) Receipt of immune globulins, blood or blood-derived products in the past 3 months 5) 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) 6) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically 7) 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 traveling to countries with high endemic or epidemic disease) 8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances 9) Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator’s opinion 10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination 11) Personal history of Guillain-Barré syndrome (GBS) 12) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine 13) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 14) 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 15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. 16) 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: Immunogenicity 1) To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers 2) To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either 3) To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers Safety To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers;Primary end point(s): Immunogenicity 1) Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA and rSBA : a) At D0 (baseline) and D30 in toddlers after having received a single dose of either MenACYW conjugate vaccine or Nimenrix®, as part of study MET54 b) At D0 (baseline) in children before receiving a booster dose of MenACYW conjugate vaccine as part of study MET62 (3 years after having received a single dose of either MenACYW conjugate vaccine or Nimenrix®) 2) Antibody titers against meningococcal serogroups A, C, Y, and W measured by rSBA and hSBA at D0 (baseline) and D30 after the administration of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers Tetanus toxoid is contained as a carrier protein in both the investigational vaccine and the control vaccine that was used in study MET54. Therefore, blood samples will also be tested to assess: 3) Antibody concentrations against tetanus toxoid at D0 (baseline) and D30 after the administration of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Ni | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Finland
Contacts
Public ContactClinical Team Leader
Sanofi Pasteur
Outcome results
None listed