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

NCT04460781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96175

Last updated 2022-05-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

Flublok Quadrivalent influenza vaccine RIV4

Route of administration: Intramuscular

BIOLOGICAL

Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4

Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460781 on ClinicalTrials.gov