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

Completed

Conditions studied: Influenza

In brief

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:

Key facts

Study ID

NCT04460781

Run by

Sanofi Pasteur, a Sanofi Company

People needed

96175

Starts

2018-09-17

Expected to finish

2022-02-28

Last updated by the study team

2022-05-24

Who can join

Age: any, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women:
• Laboratory or medical professional confirmation of pregnancy
• Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception
• Offspring:
• Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria
• Documented receipt of any other influenza vaccine at any other time during the pregnancy
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Kaiser Permanente Northern California — Oakland, California, United States

Full record on ClinicalTrials.gov

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