Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Primary outcomes

1. Number of Subjects Who Experienced Single or Multiple Medical Encounters

   Time frame: Within 6 months after any dose of MenACWY-CRM vaccination

   The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported

2. Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

   Time frame: Within 6 months after any dose of MenACWY-CRM

   All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care.

3. Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

   Time frame: Within 6 months after any dose of MenACWY-CRM

   The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first.

4. Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses

   Time frame: Within 6 months after any dose of MenACWY-CRM

   Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported

5. Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination

   Time frame: Within 6 months after any dose of MenACWY-CRM

   All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.

6. Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination

   Time frame: Within 6 months after any dose of MenACWY-CRM

   The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.