Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02554409 |
Recruitment Status :
Completed
First Posted : September 18, 2015
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment |
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Pregnancy Influenza | Biological: Quadrivalent Intradermal Influenza Vaccine (QIV) |
Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.
Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol.
Study Type : | Observational |
Actual Enrollment : | 87 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol |
Actual Study Start Date : | October 13, 2015 |
Actual Primary Completion Date : | April 30, 2019 |
Actual Study Completion Date : | April 30, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Pregnancy Cases
No Intervention as part of this protocol
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Biological: Quadrivalent Intradermal Influenza Vaccine (QIV)
No Intervention as part of this protocol |
- Number of cases and outcomes of pregnancies following exposure to QIV ID vaccine. [ Time Frame: Up to six years ]Data will be summarized using descriptive statistical methods and stratified by pregnancy outcome (spontaneous abortion, elective termination, fetal death stillbirth, live birth) and timing of vaccine exposure. Infant outcomes include birth defects and physical and social development.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Pregnant women will be enrolled in the registry prospectively (after exposure to a product but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry, but they will be analyzed separately from prospective reports.
Exclusion Criteria:
N/A

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554409
United States, California | |
San Diego, California, United States | |
United States, Florida | |
Miami, Florida, United States | |
United States, New York | |
Albany, New York, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
Nashville, Tennessee, United States |
Study Director: | Product Safety Officer | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT02554409 |
Other Study ID Numbers: |
QID02 U1111-1161-3485 ( Other Identifier: WHO ) |
First Posted: | September 18, 2015 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Fluzone Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Influenza |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |