Pregnant women have a higher risk for serious complications from influenza than nonpregnant women.1 To help prevent influenza and influenza-related complications in pregnant women, in 2004 the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) began recommending routine immunization of pregnant women with the seasonal flu shot at any stage of pregnancy.1,2 Pregnant women now routinely receive flu vaccines, and studies of these women have been reassuring.1 Safety assessment is ongoing and the FLUCELVAX QUADRIVALENT Pregnancy Registry (“Registry”) is one of the ways that pregnancy outcomes of women vaccinated against the flu are monitored.
This Registry is an observational study being conducted in the United States (US) to evaluate pregnancy outcomes in women vaccinated with FLUCELVAX QUADRIVALENT at any time during pregnancy. The purpose of the Registry is to collect information on pregnant women and the outcome of the pregnancy for mother and baby. The information collected will provide healthcare providers with a better understanding of the effect (if any) of FLUCELVAX QUADRIVALENT exposure during pregnancy.
The Registry’s objective is to evaluate pregnancy outcomes along a minimum of 600 women vaccinated with FLUCELVAX QUADRIVALENT at any time during pregnancy.
The primary outcomes of interest are major congenital malformations, preterm birth, and low birth weight. Other pregnancy outcomes of interest include spontaneous abortions and stillbirths. Pregnant women may self-enroll in the Registry if the eligibility criteria are met. It is desirable to obtain information as early as possible in the pregnancy, following informed consent.
The success of the Registry relies on pregnant women and healthcare providers to report a pregnancy if FLUCELVAX QUADRIVALENT was given at any time during the pregnancy. With your permission, we will send the study brochure and any other study materials to you to facilitate participant enrollment.
Healthcare providers and pregnant women are encouraged to contact Seqirus for more information about participation in the Registry:
References: 1. Pregnant women & influenza (flu). Centers for Disease Control and Prevention website. http://www.cdc.gov/flu/protect/vaccine/pregnant.htm. Accessed July 22, 2016. 2. Grohskopf LA, Olsen SJ, Sokolow LZ, et al; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2014-15 influenza season. MMWR Morb Mortal Wkly Rep. 15;63(32):691-697.