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Maternal Determinants of Infant Immunity to Pertussis

NCT05856396 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-13

No results posted yet for this study

Summary

The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.

Conditions

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

Interventions

BIOLOGICAL

Triaxis® (Pertussis-containing vaccine)

Triaxis® (Pertussis-containing vaccine) will be administered: * in non-pregnant women presenting to the Travel and Vaccine clinic for pertussis immunization only or hospital member staff requiring Tetanus Toxoid (TT)-booster immunisation * in Pregnant women between 16 and 29 weeks of gestation.

BIOLOGICAL

Vaxelis® (Pertussis-containing vaccine)

Vaxelis® (Hexavalent vaccine) will be proposed in infants at 8, 12 and 16 weeks of life.

Sponsors & Collaborators

  • Université Libre de Bruxelles

    collaborator OTHER

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2025-12-23
Completion
2025-12-23

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856396 on ClinicalTrials.gov