Product

Pregnancy Registry

PAXVAX

VAXCHORA® (Cholera Vaccine, Live, Oral) Pregnancy Registry has been established to monitor the safety of Vaxchora use during pregnancy.

Vaxchora® is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. To date, studies have not been performed among pregnant women who have taken Vaxchora1. The goal of the pregnancy registry is to prospectively collect data on the safety of Vaxchora® exposure on pregnant women and their offspring. The registry is strictly observational.

The Vaxchora® Pregnancy Registry will enroll women who have been immunized with Vaxchora® within 28 days prior to conception or at any time during pregnancy. Data collected for the registry will include the length of the pregnancy, the outcome of the pregnancy and the health of the mother and baby. The data collected will help us learn more about the use of Vaxchora® during pregnancy

Pregnant women will be enrolled in the Registry prospectively (after exposure to Vaxchora® in routine clinical settings but before knowledge of the pregnancy outcome). Enrollment in the Registry is voluntary. A woman may self-enroll in the Registry or her healthcare provider (HCP) can, with her consent, enroll her on her behalf. Participation in the Vaxchora® Pregnancy Registry will involve completion of an Initial Pregnancy Questionnaire at the time of enrollment and an Outcome Pregnancy Questionnaire within one month after the estimated date of delivery.

To enroll in the Vaxchora® Pregnancy Registry or to find out more information please call the registry telephone number directly(1-800-533-5899).

References

  1. Vaxchora [package insert]. Hamilton, Bermuda: PaxVax Bermuda Ltd.; 2016.

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