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Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01945424
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

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

Detailed Description:

Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.

No vaccine products will be provided or administered as part of this registry protocol.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 244 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol
Actual Study Start Date : August 16, 2013
Actual Primary Completion Date : September 15, 2019
Actual Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnancy Cases
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
 Biological: Quadrivalent Influenza Vaccine (QIV)
No Intervention as part of this protocol


Outcome Measures
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Primary Outcome Measures :
  1. Number of cases and outcomes of pregnancies following exposure to QIV 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.


Eligibility Criteria
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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 Influenza Vaccine (QIV)
Criteria

Inclusion Criteria:

  • Pregnant women will be enrolled in the registry prospectively (after exposure to Quadrivalent Influenza Vaccine (QIV) 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
Contacts and Locations
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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): NCT01945424


Locations
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United States, California
San Diego, California, United States
United States, New York
Albany, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Pennsylvania
Harrisburg, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01945424    
Other Study ID Numbers: QIV08
U1111-1143-8433 ( Other Identifier: WHO )
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Quadrivalent 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