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Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

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 : Active, not recruiting
First Posted : September 18, 2015
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.

Condition or disease Intervention/treatment
Pregnancy Influenza Biological: Quadrivalent Intradermal Influenza Vaccine (QIV)

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 300 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
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Pregnancy Cases
No Intervention as part of this protocol
Biological: Quadrivalent Intradermal Influenza Vaccine (QIV)
No Intervention as part of this protocol




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
Study Population
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Intradermal Influenza Vaccine (QIV ID)
Criteria

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


Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Product Safety Officer Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02554409     History of Changes
Other Study ID Numbers: QID02
U1111-1161-3485 ( Other Identifier: WHO )
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Fluzone Quadrivalent Intradermal Influenza Vaccine
Pregnancy Registry
Influenza

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs