B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

A Phase II, Single Center, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

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

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.