Status:
COMPLETED
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Lead Sponsor:
GlaxoSmithKline
Conditions:
Meningococcal Disease
Pregnancy
Eligibility:
FEMALE
Brief Summary
The GlaxoSmithKline's Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to prospectively collect data on ...
Eligibility Criteria
Inclusion
- Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to conception or at any time during pregnancy
- Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
- Date the pregnancy exposure is registered
- Full reporter (ie, HCP) contact information to allow for follow-up (name, address, etc.)
Exclusion
Key Trial Info
Start Date :
September 30 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2017
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02223637
Start Date
September 30 2014
End Date
December 8 2017
Last Update
June 21 2019
Active Locations (2)
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1
GSK Investigational Site
Wilmington, North Carolina, United States, 28401-3331
2
GSK Investigational Site
Wilmington, North Carolina, United States, 28401-