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The development of this pregnancy registry for Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant adsorbed), is endorsed by the European Health Authorities. The pregnancy registry is active in France, and in the United States.
What is a Pregnancy Registry? A pregnancy registry is a voluntary surveillance program that actively collects medical information on pregnant women inadvertently vaccinated during their pregnancies.
The pregnancy registry doesn't mean that there is any risk for you or your baby if you have been vaccinated during your pregnancy.
What is the aim of this pregnancy registry? The pregnancy registry is designed to collect as much information as possible for monitoring the inadvertently use of the vaccine during pregnancy.
The data collected from the pregnancy registry will be analysed and will be used to respond to inquiries from healthcare professionals on the use of the vaccine during pregnancy.
Your participation will therefore benefit other pregnant women.
What do I need to do to participate in the Pregnancy Registry? If you were inadvertently vaccinated with Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant adsorbed), one month prior to or at any time during your pregnancy, you are encouraged to report your vaccination with Gardasil®.
All you need to do is to contact your doctor or to call this free phone number: 0805.858.868 The procedure is simple:
1-Inform your doctor who follows your pregnancy that you want to take part in this registry.
2- Give your permission to collect medical information about yourself, your pregnancy and your baby by signing an informed consent form. Your participation requires a few interviews during and after your pregnancy. You will not have to make extra visits, or take any treatments.
Your doctor will collect medical information through answering specifically designed questionnaires, which will cover:
Your pregnancy and the outcome
The birth of your baby
The health of your baby, from birth up until the age of six months.
These questionnaires will be forwarded to us for data analysis.
How will my personal data be used? Your and your baby identities will remain strictly confidential.
All the medical information collected for this pregnancy registry is protected by the data protection law.
How can I get more information on the pregnancy registry? There are three ways to obtain further information about the pregnancy registry:
Call the information line (free phone number) at 0805.858.868
Fax inquiries to the information fax line (free fax number) at 0805.858.848
Send e-mail inquiries to registregrossesse@spmsd.com
If you know someone who was inadvertently vaccinated with Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] Recombinant absorbed), during her pregnancy, please inform her of the existence of this pregnancy registry.
*Your participation in this registry is really important.
Your experience will benefit other pregnant women*
Sanofi Pasteur MSD does not recommend the use of its products in any manner other than as described in the product leaflet. Please review the product information leaflet before a vaccination with Gardasil®. |
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