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

A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

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.

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.