immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine in healthy toddlers

Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections

Summary: 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®

all participants received 1 dose of menacyw conjugate vaccine or nimenrix® on day 0 and were evaluated for immunogenicity and safety profile. the duration of each participant's participation in the trial was 30 to 44 days.

Eligibility criteria:
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.

Keywords: meningitis meningococcal meningitis menacyw conjugate vaccine nimenrix®