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The development of the pregnancy registry for Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant adsorbed) is endorsed by the European Health Authorities. This pregnancy registry is active in France and in the United States.
What is a pregnancy registry? A pregnancy registry is a prospective and voluntary program designed to actively collect and evaluate medical information on all reported pregnancies and the outcomes following the administration of a pharmaceutical product.
It is a Sanofi Pasteur MSD voluntary initiative to follow-up patients and inform healthcare professionals on the safety of our vaccine during pregnancy.
What is the aim of the Gardasil® pregnancy registry? Gardasil® is intended for use in women of childbearing potential, so it is possible that pregnant women will be inadvertently vaccinated with Gardasil® during their pregnancy. The pregnancy registry is a program established to evaluate prenatal exposures to Gardasil® and to continuously monitor the safety profile of the vaccine in the post license environment.
During the prelicensure clinical development program, the data on Gardasil® administered during pregnancy did not indicate any safety signal. However, these data are insufficient to recommend use of Gardasil® during pregnancy. Vaccination should therefore be postponed until after completion of pregnancy. For further information on Gardasil® you can refer to the Summary of Product Characteristics.
Why should I advice my patient to participate in this pregnancy registry? The participation in this pregnancy registry will contribute to the collection of valuable information. This information will be used to respond to inquiries from healthcare professionals on the inadvertently use of Gardasil® during pregnancy. Data will be analysed and may be used to update the pregnancy section of the Summary of Product Characteristics as appropriate.
How to participate in the pregnancy registry? We encourage healthcare professionals to report prenatal exposure to Gardasil® during pregnancy as early in pregnancy as possible to facilitate the collection of prospective and unbiased information:
By calling the Sanofi Pasteur MSD Pregnancy Registry at 0805.858.868
Or by downloading, completing a one-page initial pregnancy form and by faxing it to the registry 0805.858.848
At the end of the pregnancy, you will be contacted to complete a one-page follow-up pregnancy form. The data collected cover the pregnancy and the delivery and the baby's health condition at birth.
The baby will be followed-up from birth until the age of six months thanks to a one page child follow-up questionnaire ideally completed by the child's physician.
Criteria for enrolment include:
- Vaccination with Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant, adsorbed) within 1 month (30 days) prior to or at anytime during pregnancy.
- Report of pregnancy from a healthcare professional or a patient, for French residents only
- Name of a healthcare professional to confirm diagnoses and to obtain outcome information
- Initials and date of birth of the patient to allow for follow-up at expected date of delivery.
The patients wishing to report a case to the pregnancy registry will be asked to read, complete, sign and date an informed consent form.
The pregnancy registry will not receive patients' or children' complete identity but only initials and dates of birth. Identities will not be communicated; it will simply allow contacting healthcare professionals in order to obtain information on patients' pregnancy course and children' health.
How are data analysed and reported by the pregnancy registry? A background report on exposure to Gardasil® during pregnancy based on preclinical and clinical safety assessment is available on request .
Reports from the pregnancy registry will be issued annually and will contain up-to-date information on product exposure during pregnancy. Annual reports could be requested by all interested healthcare professionals:
by downloading the attached Annual Report Request form and by faxing it to the Registry: 0805.858.848
or completing it online .
How can I get more information on the pregnancy registry? You can obtain further information about the pregnancy registry by:
Calling the information line (free phone number) at 0805.858.868
Faxing inquiries to the information fax line (free fax number) at 0805.858.848
Sending e-mail inquiries to registregrossesse@spmsd.com
*The success of the pregnancy registry relies on your participation and those of pregnant women inadvertently vaccinated with Gardasil®*
Sanofi Pasteur MSD does not recommend the use of its products in any manner other than as described in the Summary of Product Characteristics. Please review the full prescribing information before administering Gardasil®.
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