NCT04460781

Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 96,175 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 64 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes Secondary Objective:

Detailed description

Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flublok Quadrivalent influenza vaccine RIV4	Route of administration: Intramuscular
BIOLOGICAL	Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4	Route of administration: Intramuscular

Timeline

• Start date: 2018-09-17
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2020-07-08
• Last updated: 2022-05-24

Locations

1 site across 1 country: United States