The optimal timing of vaccination in pregnancy

Phase 1

• Conditions: humoral and cellular immune responses to pertussis vaccine during pregnancy; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-005194-77-BE
• Lead Sponsor: niversity of Antwerp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-05
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

•Female population older than 18 years.
•Ability to provide informed consent.
•Willing to be vaccinated with a Tdap vaccine during pregnancy.
•Intend to be available for follow-up visits and phone call access until 6 months postvaccination.
•Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Vaccinated with an aP containing vaccine during the last 5 years
•Significant mental illness (e.g. schizophrenia, psychosis, major depression)
•Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human
immunodeficiency virus (HIV) infection…).
•Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg
prednisone or equivalent.
•Anything in the opinion of the investigator that would prevent volunteers from completing the study or
put the volunteer at risk.
•Previous severe reaction to any vaccine
•High risk for serious obstetrical complications.

Study & Design

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