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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections
Interventions: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
Countries: Finland
The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine. Observational objectives: * To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA) * To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine * To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
Sex: ALL
Age: 12 Months to 23 Months
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Aged 12 to 23 months on the day of the first study visit. * Born at full term of pregnancy (greater than or equal to \[≥\] 37 weeks) or with a birth weight ≥2.5 kilogram (kg) (5.5 pounds). * Inform Consent Form (ICF) had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations). * Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures. * Covered by health insurance where applicable. Exclusion Criteria: * Participation at the time of study enrollment (or 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. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccine. * Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or Conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. * 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 (≥ 2 milligram \[mg\]/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * At high risk for meningococcal infection during the trial (i.e., participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease). * 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. * Known systemic hypersensitivity to latex. * Known thrombocytopenia, as reported by the parent/legally acceptable representative. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0 degree Celsius (°C). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
- Espoo, Finland
- Helsinki, Finland
- Helsinki, Finland
- Jarvenpaa, Finland
- Oulu, Finland
- Pori, Finland
- Tampere, Finland
- Turku, Finland