Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry
2 other identifiers
observational
87
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2015
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2015
CompletedFirst Posted
Study publicly available on registry
September 18, 2015
CompletedStudy Start
First participant enrolled
October 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedFebruary 12, 2020
February 1, 2020
3.5 years
September 16, 2015
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of cases and outcomes of pregnancies following exposure to QIV ID vaccine.
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.
Up to six years
Study Arms (1)
Pregnancy Cases
No Intervention as part of this protocol
Interventions
No Intervention as part of this protocol
Eligibility Criteria
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Intradermal Influenza Vaccine (QIV ID)
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
San Diego, California, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Nashville, Tennessee, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Product Safety Officer
Sanofi Pasteur Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2015
First Posted
September 18, 2015
Study Start
October 13, 2015
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02