NCT03888989

Response to Influenza Vaccine During Pregnancy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent inactivated influenza vaccine (IIV)	Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-03-25
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study