NCT02223637

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

MENVEO Pregnancy Registry: an Observational Study on the Safety of MENVEO Exposure in Pregnant Women and Their Offspring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	Meningococcal quadrivalent CRM-197 conjugate vaccine	This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.

Timeline

• Start date: 2014-09-30
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2014-08-22
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

2 sites across 1 country: United States