Maternal Determinants of Immunity to Influenza

NCT ID: NCT06716567

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2023-11-10

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Pregnant women

Pregnant women receive one dose of influenza-containing vaccine during pregnancy.

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Alpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively.

Non-pregnant women

Non-pregnant women receive one dose of influenza-containing vaccine.

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Alpharix-Tetra®, Vaxigrip Tetra® and Influvac Tetra® were used as influenza vaccines in the 2020-2021, 2021-2022, and 2022-2023 seasons respectively.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age over 18 and under 40 years.

Exclusion Criteria

• Grade III/IV anemia
• Human Immunodeficiency Virus (HIV) infection
• Active bacterial infection
• Opportunistic infection (Tuberculosis, cytomegalovirus (CMV), toxoplasmosis, etc)
• Inability to understand the nature and extent of the study and the procedures required
• Current or recent use of immunosuppressive drugs (corticosteroids, anti-tumor necrosis factors (anti-TNF), methotrexate, etc)
• Active neoplasia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Medical Immunology, Université libre de Bruxelles

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Dauby

Clinical Professor, Infectious Disease Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Saint-Pierre

Brussels, , Belgium

Countries

Belgium

Other Identifiers

B762020201013

Identifier Type: -

Identifier Source: org_study_id