Response to Influenza Vaccine During Pregnancy — FLU-PG  

Influenza Clinical Trial

Official title: Response to Influenza Vaccine During Pregnancy

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a Phase I mechanistic 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 ;

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT03888989
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2019
• Completion date: December 31, 2023