Immunization during pregnancy is an efficient and safe approach to provide protection against infectious pathogens affecting the young infant. The objective is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. A systems biology approaches 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.

Phase 1

• Conditions: Vaccination against whooping cough in non-pregnant women and in pregnant women.Vaccination against whooping cough in the Belgian vaccination program in children from 2 months of age; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-002697-80-BE
• Lead Sponsor: niversité Libre de Bruxelles

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-12
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Eligibility of pregnant and non-pregnant women
-Age between 18 and 45 years
-Eligible for Tdap vaccination
-Last Pertussis vaccination < 12 months ago
- Consent form signed

2.Eligibility of infants:
-Infants of 2 months (+- 1 week) of age (boys and girls)
-Born after 35 weeks of gestation
-Birthweight above 2.5 kg
-Consent form signed by the parents

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Exclusion criteria (non-pregnant women and pregnant women):
-Inability to understand the nature and extent of the study and the procedures required
-Grade III/IV anemia,
-Acute infection at the time of immunization
-Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
-Current or recent use of immunosuppressive drugs
-Active neoplasia
-Other vaccination at the same time as pertussis vaccination
Specific to pregnant women:
-Risk of premature delivery or intrauterine growth retardation
-Twin or triplet pregnancies

2. Exclusion criteria (infants):

-Severe neonatal distress
-Serious congenital abnormalities or congenital infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified