A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate 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:
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):
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:
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.