B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM; DTaP-Hib-IPV; PCV; MMR; Hib
Intervention description: One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.; IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.; IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh.; IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh.; IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right 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: 216.0
Sex: All
Minimum age: 56 Days
Maximum age: 83 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; Prevention; Vaccination

Summary:

      This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135
      and Y specific memory B Cells, measured 1 month after a primary vaccination series of
      Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human
      complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who were eligible to be enrolled in the study:

          -  healthy infants aged 2 months (56 - 83 days old, inclusive);

          -  available for the visits scheduled in the study;

          -  mother available for blood draw at Visit 1;

          -  good health as determined by the clinical judgement of the investigator;

          -  whose parents gave written informed consent for the infant to be enrolled in the
             study. The infant's parents must have been willing for the infant to receive the full
             primary immunization course.

        Exclusion Criteria:

        Subjects who were not eligible for the study were those:

          -  whose parents had not given or were unwilling or unable to give written informed
             consent to their child's participation in the study

          -  with known hypersensitivity to any vaccines contained within the routine immunization
             schedule

          -  with unacceptable concurrent illnesses or conditions - e.g.:

               1. a severe acute or chronic illness; with any present or suspected serious disease
                  such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or
                  with any other serious disease (e.g., with signs of cardiac or renal failure or
                  severe malnutrition), including progressive neurological disease;

               2. a genetic anomaly, e.g. Down's syndrome;

               3. any immunodeficiency, including use of systemic corticosteroids;

               4. born at less than 36 weeks gestation;

               5. weighing less than 2.5 kg at birth;

               6. previous clinical or bacteriological diagnosis of meningitis, or with a history
                  of household contact or intimate exposure to an individual with culture proven
                  Neisseria meningitidis disease;

               7. known bleeding diathesis, or any condition associated with a prolonged bleeding
                  time;

          -  who have received any prohibited prior or concomitant medications - e.g.:

               1. any immunizations within the 30 days prior to enrollment, with the exception of
                  BCG or hepatitis B;

               2. immunoglobulin;

               3. any blood products;

          -  participating in any other clinical trial either currently or in the previous month;

          -  unable to adhere to the protocol, including plans to move from the area;

          -  Other:

        Had any condition which, in the opinion of the investigator, might interfere with the
        evaluation of the study objectives.