Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Inclusion Criteria

Individuals eligible for enrollment in this study were male, and female infants:

• Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg;
• For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
• Who were available for all the visits scheduled in the study;

• Who were in good health as determined by:

  • Medical history;
  • Physical examination;
  • Clinical judgment of the investigator.

Exclusion Criteria

Ineligible for the study were infants:

• Whose parents/legal guardians were unwilling, or unable to give written informed consent for the subject to participate in the study;
• Who previously received any meningococcal vaccine;
• Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV, HBV, H influenzae type b (Hib), or Pneumococcus;
• Who had a previously ascertained or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis (history of laboratory-confirmed or clinical condition of spasmodic cough for a period ≥ 2 weeks associated with apnea or whooping cough);
• Who had household contact with and/or intimate exposure to an individual with laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection since birth;
• Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component;
• Who had experienced significant acute or chronic infection within the previous 7 days, or fever (≥ 38.0°C) within the previous 3 days;
• Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition, or insulin-dependent diabetes); or progressive neurological disease; or a genetic anomaly or known cytogenic disorders (e.g., Downs syndrome);

• Who had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):

  • receipt of any immunosuppressive therapy since birth;
  • receipt of immunostimulant since birth;
  • receipt of any systemic corticosteroid since birth.
• Who had a suspected or known HIV infection, or HIV-related disease;
• Who had ever received blood, blood products and/or plasma derivatives, or any parenteral immunoglobulin preparation;
• Who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;

• Who had a history of seizure disorder:

  • Febrile seizure;
  • Any other seizure disorder.
• Who had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose);
• Who with their parents/legal guardians were planning to leave the area of the study site before the end of the study period;
• Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
• Who had taken any antipyretic medication in the previous 6 hours.