Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

• Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.*
• Born after a full-term pregnancy, with an estimated gestation age >= 37 weeks and a birth weight >= 2.5 kilograms.
• Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
• Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
• In good health as determined by medical history and physical assessment.
• For the Russian Federation: The participant's parents were able to verbally report or provide written documentation that the participant's mother was hepatitis B antigen negative during pregnancy with the participant.
• * "2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days).
• † In the Russian Federation, as per local regulations, only the participant's parent(s) were entitled to sign an informed consent form. A child under the responsibility of a guardian would not be included in the study.

Exclusion criteria

An individual fulfilling any of the following criteria was to be excluded from trial enrollment:

• Participation at the time of study enrollment or in the 4 weeks preceding the first 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., meningitis polysaccharide or meningitis Conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella.
• For Mexico: More than 1 previous dose of hepatitis B vaccine.
• Receipt of immune globulins, blood or blood-derived products since birth.
• 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) since birth.
• Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
• Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• Individuals with active tuberculosis.
• History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / disease.
• At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
• History of intussusception.
• History of any neurologic disorders, including seizures (febrile and non-febrile) and progre