NCT06716567

Maternal Determinants of Immunity to Influenza

Maternal Determinants of Immunity to Influenza (MADI-01)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The overall objective of the project is to determine the impact of pregnancy on the response to influenza immunization.

Detailed description

The study compares immune responses to influenza vaccination between a group of pregnant women and a group of non-pregnant controls women. Specifically, the study has three aims: 1. To compare the quality of antibodies induced by influenza immunization in pregnant and non-pregnant women; 2. To identify immune predictors of vaccine responses in pregnant women and compare them to the determinants of vaccine responses in non-pregnant women; 3. To identify immune predictors of the transfer of maternal antibodies to the newborn following influenza immunization during pregnancy;

Conditions

• Vaccination; Infection
• Maternal-Fetal Relations
• Influenza
• Immunoglobulins

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccine	Alpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively.

Timeline

• Start date: 2020-11-16
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2024-12-04
• Last updated: 2025-03-24

Locations

1 site across 1 country: Belgium