Menveo® pregnancy registry: an observational study on the safety of Menveo exposure in pregnant women and their offspring
Menveo® pregnancy registry is established to meet a post marketing commitment agreed upon with CBER to establish a pregnancy registry to prospectively collect data on pregnancy exposures to Menveo. This registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by the treating health care provider.
The objective of the Menveo Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the Menveo vaccine within 28 days prior to conception or at anytime 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.
The registry has multiple enrolment channels. It allows eligible pregnant women to self-enroll and also allow HCPs and/or health maintenance organizations to report de-identified data on pregnancy exposures and outcomes.
This registry is primarily descriptive and designed to detect potential safety signals rather than test hypotheses.
The registry population includes pregnant women within the United States who were immunized with the Menveo vaccine within 28 days prior to conception or at any time during pregnancy.
The minimum criteria required for enrollment into the registry are as follows:
For more information please contact PPD via the information below:
Estimated Enrollment: 100