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

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

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:

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Flublok Quadrivalent influenza vaccine RIV4; Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

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 Type: Observational
• Enrollment (Actual): 96175

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 64 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Women were not randomized. A modified-cluster randomization scheme was used. Facilities were assigned to blocks and were randomized within blocks, ensuring that roughly half the facilities within each block initially administer one vaccine of the 2 vaccines planned in the study, and the other half administer the alternate vaccine. Iteratively, over time, the vaccine administered within each facility will then alternate.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 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	Biological: Flublok Quadrivalent influenza vaccine RIV4; Route of administration: Intramuscular; Other Names: RIV4; Biological: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4; Route of administration: Intramuscular; Other Names: SD-IIV4

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VAP00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No