What can research teach us about pregnancy and influenza vaccines?
Learn how you can participate in an observational research study for pregnant women who have been vaccinated with influenza vaccine products.
Seqirus has initiated a pregnancy registry to monitor the use of two Seqirus influenza vaccines that are available on the U.S. market; AFLURIA® QUADRIVALENT and FLUCELVAX® QUADRIVALENT. Below more information can be found on whether you are eligible for participation and what to expect when you are enrolled.
Research Study Information
|The information on Seqirus influenza vaccine pregnancy registries is intended for patients (consumers) and healthcare providers, who, before any knowledge of the pregnancy outcome, wish to enroll a pregnancy already exposed to a certain Seqirus influenza vaccine into our registry.|
|Because you are pregnant and have received a Seqirus influenza vaccine|
|You have the opportunity to participate in an observational research study. In this study, medical information about you and your baby will be collected, both during your pregnancy and after delivery. As a study participant, you will not receive any drugs not approved by the FDA, make any extra visits to the doctor, or undergo any additional tests. Only your healthcare provider will schedule visits, tests, or treatments you may need to receive during and after your pregnancy. You will not be asked to do anything outside of your regular medical care.|
|Why is this study being conducted?|
|Pregnant women have a higher risk of developing serious complications from influenza than non-pregnant women (Rasmussen, 2012). However, the safety of pregnant women receiving influenza vaccines is not fully known. As a result, information about pregnant women receiving influenza vaccines needs to be collected. By collecting this information, healthcare providers will learn more about the effects (if any) of Seqirus influenza vaccine on pregnant women and their babies.|
|Who is eligible to participate in this study?|
|To pre-qualify for this study, you must:
• Be a pregnant female in the United States
• Have received AFLURIA® QUADRIVALENT (influenza vaccine) or FLUCELVAX® QUADRIVALENT (influenza vaccine) as part of routine care at any time during your pregnancy
|What does participation in this study involve?|
|If you are eligible for this study, you will be asked to give your consent for the study to collect personal information from your health care provider about you and your baby. An example of an informed consent form for this study can be found here. The study will not collect any personal information about you or your baby without your consent.
If you do give your consent, the study will collect information about:
• Your medical condition
• Your general health during pregnancy
• Your baby’s health during pregnancy and at birth
Your participation will only consist of receiving the regular medical care provided by your health care provider. You will not be required to do anything else, and there will be no follow-up of your baby after birth.
The study will also take steps to protect your privacy and medical information. Your identifying and medical information will be kept confidential within the limits of applicable laws, rules, and regulations. Outside of disclosing your information collected during the study with the contracted staff and Seqirus, no personal information that identifies you or your baby will be revealed.
|What are the benefits of this study?|
|The success of this study relies on pregnant women and health care providers to voluntarily report information. While there may be no direct benefit to you or your baby, your participation may benefit pregnant women and babies in the future.
|For Healthcare Providers|
|Providers will only be asked to provide personal information that is routinely collected in the usual course of care. They will be contacted at registration, at the end of the second trimester, and at the end of pregnancy term. An example of the Registration form can be found here.
An expert Scientific Advisory Committee reviews the study data independently of Seqirus. This committee includes experts in Maternal and Fetal Medicine, Teratology, and Epidemiology.
The data is summarized in reports, which are submitted to governmental regulatory agencies annually, and upon completion of the study.
To enroll a patient in this study, please assist your patient in contacting the study, or call Seqirus Medical Information at 1-855-358-8966.