Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for Groups I (MenACWY-CRM_6-12 M) and II (MenACWY-CRM_12 M)

Subjects eligible for enrollment in the study were healthy infants:

1. who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;
2. who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
4. who were available for all the visits scheduled in the study;
5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.

Inclusion criteria for Group III (MenC-CRM_12 M_MenACWY-CRM_18 M)

Subjects eligible for enrollment in the study were healthy infants:

1. who were 12 months old;
2. who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;
3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
4. who were available for all the visits scheduled in the study;
5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.

Exclusion criteria:

Subjects were not to be included in this study if:

1. their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
2. they previously received any meningococcal vaccine;
3. they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
4. they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
5. they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;
6. they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);
7. they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):

   * any immunosuppressive therapy since birth;
   * immunostimulants since birth;
   * any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days;
8. they had a suspected or known HIV infection or HIV-related disease;
9. they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;
10. they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
11. they had a history of seizure disorder:

    * febrile seizure;
    * any other seizure disorder;
12. they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic \[e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin\] could have been enrolled 7 days following the last dose);
13. their parents/legal guardians were planning to leave the area of the study center before the end of the study period;
14. they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.