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.

Eligibility Criteria:

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:

• 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.)

For more information please contact PPD via the information below:

Enrollment:

Estimated Enrollment: 100
Study Start Date: September 30 2014
Estimated Primary Completion Date: July 31 2018
Estimated Completion Date: February 28 2019

Additional resources:

• Contact Us Form for Menveo Pregnancy Registry (PDF Format)
• Patient Registration Form for Menveo Pregnancy Registry (PDF format)
• Menveo Prescribing Information
• Brochure for Menveo Pregnancy Registry (PDF Format)