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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04460781

Acronym

VAP00007

Enrollment

96175

Registered

2020-07-08

Start date

2018-09-17

Completion date

2022-02-28

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

BIOLOGICALFlublok Quadrivalent influenza vaccine RIV4

Route of administration: Intramuscular

BIOLOGICALStandard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Route of administration: Intramuscular

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026