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NCT02640677 · ClinicalTrials.gov registry record
Safety of 4CMenB Exposure During Pregnancy
A clinical trial of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 2
- Enrollment target
- 1
- Study location
NCT02640677: Completed study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT02640677 is a study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 2 participants, below the 524-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02640677, a study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy.
Conditions Studied
Interventions
- BIOLOGICAL 4CMenB
Study Locations (1)
North Carolina
- GSK Investigational Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2016-01-31 |
| Est. Completion | 2019-11-30 |
What the finished NCT02640677 record still lists
NCT02640677 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 524-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Infections, Meningococcal appearing as the primary indexed condition, and to 1 intervention - of which 4CMenB is the first listed.
NCT02640677 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02640677 about?
NCT02640677 is a clinical study titled "Safety of 4CMenB Exposure During Pregnancy". 4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows sh...
What is the current status of trial NCT02640677?
This trial is currently completed. The enrollment target is 2 participants. The study started on 2016-01-31. Estimated completion is 2019-11-30.
What conditions does trial NCT02640677 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT02640677?
The interventions under investigation include: 4CMenB (BIOLOGICAL).
Who is sponsoring clinical trial NCT02640677?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02640677 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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