Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
2 other identifiers
observational
244
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2013
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2013
CompletedFirst Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2019
CompletedFebruary 12, 2020
February 1, 2020
6.1 years
September 13, 2013
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of cases and outcomes of pregnancies following exposure to QIV 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
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
Interventions
No Intervention as part of this protocol
Eligibility Criteria
Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)
You may qualify if:
- 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.
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
Albany, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Harrisburg, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Related Publications (1)
Ledlie S, Gandhi-Banga S, Shrestha A, Mallett Moore T, Khromava A. Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. Influenza Other Respir Viruses. 2022 Jan;16(1):90-100. doi: 10.1111/irv.12897. Epub 2021 Sep 14.
PMID: 34520127DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2013
First Posted
September 18, 2013
Study Start
August 16, 2013
Primary Completion
September 15, 2019
Study Completion
September 15, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02