Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring (VAP00007)

Sanofi

Status: Completed

Conditions: Influenza

Treatments: Biological: Flublok Quadrivalent influenza vaccine RIV4; Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Study type: Observational

Funder types: Industry

Identifiers

NCT04460781

VAP00007

Details and patient eligibility

About

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:

Full 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.

Enrollment: 96,175 patients

Sex: All

Ages: Under 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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.

Trial design

96,175 participants in 1 patient group

1

Description:

Pregnant women from the VAP00003 Study and their offspring - Pregnant women from the VAP00003 Study (NCT03694392) between September 2018 and May 2020 (2 influenza seasons), and infants born from this cohort of pregnant women

Treatment:

Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Biological: Flublok Quadrivalent influenza vaccine RIV4