- Investigators should always use good clinical judgment in considering a subject's
overall fitness for trial participation. In addition, any condition that in the
opinion of the investigator may interfere with the evaluation of study objectives
should be carefully considered prior to enrolling subjects.
- Male or female subjects aged 2 months (42 to 98 days of age) at the time of
- Available for the entire consented period and whose parent/legal guardian can be
reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of
- Parent/legal guardian must be able to complete all relevant study procedures during
- Previous vaccination with licensed or investigational vaccines: meningococcal B,
meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis,
poliovirus, rotavirus, varicella, measles, mumps, or rubella.
Any of the following illnesses/conditions that, in the investigator's judgment, will
substantially increase the risk associated with the subject's participation in and
completion of the study:
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal,
Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus,
rotavirus, varicella, measles, mumps, or rubella.
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by N meningitidis or Neisseria
- Major known congenital malformation or serious chronic disorder.
- Significant neurological disorder or history of seizure including febrile seizure, or
significant stable or evolving disorder such as cerebral palsy, encephalopathy,
hydrocephalus, or other significant disorder.
Does not include resolving syndromes due to birth trauma such as Erb palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
- Received any investigational drugs, vaccines or devices (aside from those specified in
the protocol) within 4 weeks before administration of the first dose of test article
or at any time throughout the study.
- Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child, grandchild) of the study site personnel.