Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
Overview
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.
Full Title of Study: “Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: September 15, 2019
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.
Interventions
- Biological: Quadrivalent Influenza Vaccine (QIV)
- No Intervention as part of this protocol
Arms, Groups and Cohorts
- Pregnancy Cases
- Pregnant women exposed to Sanofi Pasteur’s Quadrivalent Influenza Vaccine (QIV)
Clinical Trial Outcome Measures
Primary Measures
- 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.
Participating in This Clinical Trial
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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Clinical Sciences & Operations, Study Director, Sanofi Pasteur, a Sanofi Company
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