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Safety of 4CMenB Exposure During Pregnancy
NCT02640677 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02640677
The ClinicalTrials.gov registry entry for NCT02640677 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02640677 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02640677?
The interventions under investigation include: 4CMenB (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02640677?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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