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

Influenza Clinical Trial

— VAP00007  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460781
• Other study ID #: VAP00007
• Status: Completed
• Start date: September 17, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: May 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96175
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flublok Quadrivalent influenza vaccine RIV4
Route of administration: Intramuscular
• Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4
Route of administration: Intramuscular

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence Rates of Birth Events	Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth	At birth
Primary	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