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NCT02554409 Clinical Trial

Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

Pregnancy Clinical Trial

Official title:
Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02554409
Other study ID # QID02
Secondary ID U1111-1161-3485
Status Completed
Phase
First received
Last updated
Start date October 13, 2015
Est. completion date April 30, 2019

Study information
Verified date February 2020
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.

Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

N/A

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Quadrivalent Intradermal Influenza Vaccine (QIV)
No Intervention as part of this protocol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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