Response to Influenza Vaccine During Pregnancy (FLU-PG)

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Stanford University
Updated on 5 February 2023
vaccination
trivalent influenza vaccine
quadrivalent inactivated influenza vaccine
Accepts healthy volunteers

Summary

This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to vaccination in pregnancy.

Description

This is a Phase IV study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy.

Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons.

Study procedures:

Year One:

First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination.

2nd and 3rd visits: 20 ml blood will be obtained

Year Two:

First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained

Details
Condition Influenza
Treatment Quadrivalent inactivated influenza vaccine (IIV)
Clinical Study IdentifierNCT03888989
SponsorStanford University
Last Modified on5 February 2023

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