Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/5/2018 |
| Start Date: | December 1, 2014 |
| End Date: | November 29, 2017 |
Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (MENVEO®) in Children 2 Months Through 23 Months of Age.
This safety surveillance study of Novartis 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.
(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.
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:
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