Maternal Determinants of Immunity to Influenza

NCT06716567 | Completed Phase 4

• 1 other identifier: B762020201013
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Haemagglutination Inhibition Assay titre

  Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \>=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * Non-pregnant women

  28 days post vaccination

• Haemagglutination Inhibition Assay titre

  Haemagglutination Inhibition Assay (HAI) titres are used to measure responses to relevant influenza strains. The HAI method exploits the property of the influenza virus to haemagglutinate red blood cells. HAI titres are determined as the highest serum dilution inhibiting haemagglutination. An HAI titre of \>=40 is considered protective in adults. HAI titres will be measured in : * Pregnant women * In umbilical cord blood

  At delivery

Secondary Outcomes (4)

• Haemagglutination inhibition assay titre

  up to 11 months after vaccination

• Micro neutralization assay titre

  up to 11 months after vaccination

• Influenza virus specific IgG titre

  up to 11 month after vaccination

• Influenza virus specific IgG antibody avidity

  up to 11 months after vaccination

Study Arms (2)

Pregnant women

ACTIVE COMPARATOR

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

Biological: Influenza vaccine

Non-pregnant women

ACTIVE COMPARATOR

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

Biological: Influenza vaccine

Interventions

Influenza vaccine 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; Pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age over 18 and under 40 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Université Libre de Bruxelles: collaborator

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Infections; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers analyzing the immunological outcomes are blinded to the groups of the subjects (pregnant vs non-pregnant).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Infectious Disease Department

Model Details: Pregnant women and non-pregnant women are recruited in parallel.

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: November 16, 2020
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1)