N/A
Completed N=138
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
Meningococcal Disease · Infections, Meningococcal
Source: ClinicalTrials.gov NCT02287688 ↗
Enrolled (actual)
138
Serious AEs
—
Results posted
Oct 2019
Primary outcomePrimary: Number of Subjects Who Experienced Single or Multiple Medical Encounters — 16; 24 Participants
Summary
This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration.
It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member.
The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Experienced Single or Multiple Medical Encounters |
16; 24 | — |
| PRIMARY Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination |
102; 32; 57; 13 | — |
| PRIMARY Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination |
0.4; 0.6; 0.1 | — |
| PRIMARY Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses |
6; 34 | — |
| PRIMARY Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination |
2; 1; 1; 1; 1; 2 | — |
| PRIMARY Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- children 2-23 months of age at the time of MenACWY-CRM vaccination
- hold KPSC membership at the time of MenACWY-CRM vaccination
- vaccinated with MenACWY-CRM during the study period in KPSC
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02287688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.