immunogenicity and safety of menacwy in infants (6 & 12 months)

Conditions: Meningococcal Meningitis

Summary: 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.

Keywords: meningitis children vaccine