Clinical Trial: Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary:

The Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine pregnancy registry is stablished to meet a post marketing commitment agreed upon with CBER to prospectively collect data on pregnancy exposures to Novartis Meningococcal quadrivalent CRM-197 conjugate vaccine.

It is an observational study of women inadvertently immunized with the Novartis 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.


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Major congenital malformation [ Time Frame: From enrollment (during pregnancy) to pregnancy outcome available i.e. Upto 1 Year ]
  • Preterm birth [ Time Frame: From enrollment (during pregnancy) to pregnancy outcome available i.e. Upto 1 Year ]
  • Low birth weight [ Time Frame: From enrollment (during pregnancy) to pregnancy outcome available i.e. Upto 1 Year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Spontaneous abortions [ Time Frame: From enrollment (during pregnancy) to pregnancy outcome available i.e. Upto 1 Year ]
  • Stillbirths [ Time Frame: From enrollment (during pregnancy) to pregnancy outcome available i.e. Upto 1 Year ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: August 20, 2014
Date Started: September 1, 2014
Date Completion: August 30, 2018
Last Updated: May 17, 2017
Last Verified: May 2017