Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Completed

Conditions studied: Pregnancy, Influenza

In brief

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.

Key facts

Study ID

NCT01945424

Run by

Sanofi Pasteur, a Sanofi Company

People needed

244

Starts

2013-08-16

Expected to finish

2019-09-15

Last updated by the study team

2020-02-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Study site — San Diego, California, United States
• Study site — Albany, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Harrisburg, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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