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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: Completed study of Pregnancy and Infections, Meningococcal, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births
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 |
What the finished NCT02223637 record still lists
NCT02223637 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02223637's enrollment target sits among peer trials
93 122nd of 191 higher than 70 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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