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Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

NCT02223637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2019-06-21

Study results available
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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

  • Meningococcal Disease
  • Pregnancy
  • Infections, Meningococcal

Interventions

BIOLOGICAL

Meningococcal quadrivalent CRM-197 conjugate vaccine

This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-12-08
Completion
2017-12-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223637 on ClinicalTrials.gov