Actively Recruiting

Age: 1Day - 2Months
All Genders
Healthy Volunteers
NCT05266664

Preterm Immune System Development and Response to Immunization

Led by Maastricht University Medical Center · Updated on 2024-03-20

145

Participants Needed

7

Research Sites

185 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

M

Medical Center Haaglanden

Collaborating Sponsor

AI-Summary

What this Trial Is About

In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.

CONDITIONS

Official Title

Preterm Immune System Development and Response to Immunization

Who Can Participate

Age: 1Day - 2Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infant born at gestational age less than 32 weeks (mothers may or may not have received Tdap vaccination during pregnancy)
  • Parents or guardians must have sufficient understanding of the Dutch language
  • Healthy full-term infant whose mother received a Tdap vaccination during pregnancy
  • Mother of preterm or healthy full-term infant who are participating in the study
Not Eligible

You will not qualify if you...

  • Parents or guardians of the infant are not able or willing to provide informed consent
  • Infant with congenital anomalies likely to cause adverse effects after immunization, such as hemodynamically significant congenital heart defect
  • Infant with a possible HIV infection or immunodeficiency
  • Maternal use of immunosuppressive drugs during pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Amphia Hospital

Breda, Netherlands, 4819 EV

Actively Recruiting

2

reinier de Graaff Group

Delft, Netherlands, 2625 AD

Actively Recruiting

3

Albert Schweitzer Hospital

Dordrecht, Netherlands, 3318 AT

Actively Recruiting

4

Erasmus MC

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

5

Franciscus Gasthuis

Rotterdam, Netherlands, 3045 PM

Actively Recruiting

6

Maasstad Hospital

Rotterdam, Netherlands, 3079 DZ

Actively Recruiting

7

Maxima Medical Center

Veldhoven, Netherlands, 5504 DB

Actively Recruiting

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Research Team

G

Gertjan Driessen, Prof MD PhD

CONTACT

J

Jantien Bolt-Wieringa, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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