Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/6/2018 |
| Start Date: | September 30, 2014 |
| End Date: | December 8, 2017 |
MENVEO® Pregnancy Registry: an Observational Study on the Safety of MENVEO Exposure in Pregnant Women and Their Offspring
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.
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.
Inclusion Criteria:
- Sufficient evidence to confirm that MENVEO exposure occurred within 28 days prior to
conception or at any time during pregnancy
- Sufficient information to determine whether the pregnancy is prospectively or
retrospectively registered (ie, whether the outcome of pregnancy was known at the time
of first contact with the registry)
- Date the pregnancy exposure is registered
- Full reporter (ie, HCP) contact information to allow for follow-up (name, address,
etc.)
Exclusion Criteria:
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