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

Completed

• Conditions: Influenza
• Interventions: Biological: Flublok Quadrivalent influenza vaccine RIV4; Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

• Registration Number: NCT04460781
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4	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
1	Flublok Quadrivalent influenza vaccine RIV4	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

Primary Outcome Measures

Name	Time	Method
Incidence Rates of Pregnancy Outcome Events	From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome	Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption
Incidence Rates of Birth Events	At birth	Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth
Incidence Rates of Neonatal/ Infant Outcomes	From birth to Day 365 post-birth	Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States