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NCT02223637 · ClinicalTrials.gov registry record
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
A clinical trial of Pregnancy and Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 93
- Enrollment target
- 2
- Study locations
NCT02223637 is a study of Pregnancy and Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02223637, a study of Pregnancy and Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 93 participants
- Enrollment target
- 2
- Study locations
Study 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 pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine. It is an observational study of women inadvertently immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy as part of routine care. The objective of the pregnancy registry is to evaluate pregnancy outcomes among women immunized with the Meningococcal quadrivalent CRM-197 conjugate vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal quadrivalent CRM-197 conjugate vaccine
Study Locations (2)
North Carolina
- GSK Investigational Site - Wilmington
- GSK Investigational Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2014-09-30 |
| Est. Completion | 2017-12-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02223637
The ClinicalTrials.gov registry entry for NCT02223637 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Meningococcal quadrivalent CRM-197 conjugate vaccine is the first listed.
NCT02223637 reports 2 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02223637 about?
NCT02223637 is a clinical study titled "Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry". 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 pregnancy exposures to Meningococcal quadrivalent CRM-197 conjugate vaccine. It is an observational...
What is the current status of trial NCT02223637?
This trial is currently completed. The enrollment target is 93 participants. The study started on 2014-09-30. Estimated completion is 2017-12-08.
What conditions does trial NCT02223637 study?
This clinical trial studies the following conditions: Pregnancy, Infections, Meningococcal, Meningococcal Disease.
What interventions are being tested in trial NCT02223637?
The interventions under investigation include: Meningococcal quadrivalent CRM-197 conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02223637?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02223637 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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