A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

Exclusion Criteria

• •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
• •Planned participation in another clinical trial during the present trial period.
• •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• •Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with the exception of influenza vaccine, which may be received 14 days before or after MenACYW Conjugate vaccine.
• •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
• •Receipt of blood or blood-derived products in the past 30 days, which might interfere with assessment of the immune response.
• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks).
• •Known personal or maternal seropositivity for human immunodeficiency virus (HIV), hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian.
• •History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• •At high risk for meningococcal infection during the trial.
• •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.
• •Thrombocytopenia, as reported by the parent/guardian.
• •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• •History of seizures.
• •Personal or family history of Guillain-Barré Syndrome (GBS).
• •Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
• •Temporary contraindications were resolved before vaccination:
• •Febrile illness (temperature ≥38.0 degree Celsius \[≥100.4 degree Fahrenheit\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.
• •Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops were not included in this exclusion criterion. (Note: This did not applied to the other groups at this time, as they did not have a blood draw within 30 days of the initial visit.).