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OpenTrials
Completed

NCT Number: NCT04460781

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:

Completed

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flublok Quadrivalent influenza vaccine RIV4

Biological

Route of administration: Intramuscular

Other names: RIV4

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Biological

Route of administration: Intramuscular

Other names: SD-IIV4

Primary outcomes

  1. Incidence Rates of Pregnancy Outcome Events

    Time frame: 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

  2. Incidence Rates of Birth Events

    Time frame: At birth

    Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth

  3. Incidence Rates of Neonatal/ Infant Outcomes

    Time frame: From birth to Day 365 post-birth

    Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Acronym: VAP00007

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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