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

NCT04460781 | Completed

• 1 other identifier: VAP00007
• Study Type: observational
• Target: 96,175
• Locations: 1 country
• Sites: 1

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:

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Flublok Quadrivalent influenza vaccine RIV4 BIOLOGICAL

Route of administration: Intramuscular

Also known as: RIV4

1

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4 BIOLOGICAL

Route of administration: Intramuscular

Also known as: SD-IIV4

1

Eligibility Criteria

• Age: Up to 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: September 17, 2018
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)