Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenACWY-CRM; MenC-CRM; DTaP-Hib-IPV; PC7; MMR; Varicella
Intervention description: Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.; One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.; One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningitis; children; vaccine

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.