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NCT01945424 Clinical Trial

Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Pregnancy Clinical Trial

Official title:
Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01945424
Other study ID # QIV08
Secondary ID U1111-1143-8433
Status Completed
Phase
First received
Last updated
Start date August 16, 2013
Est. completion date September 15, 2019

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

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 244
Est. completion date September 15, 2019
Est. primary completion date September 15, 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 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Quadrivalent 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 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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