Clinical Trial

Preterm Immune System Development and Response to Immunization

Study acronym: PRIMI
Unknown
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Record status
This record was last updated March 20, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT05266664
Lead Sponsor Maastricht University Medical Center
Collaborators: Medical Center Haaglanden, Amphia Hospital, Albert Schweitzer Hospital, Franciscus Gasthuis, Maasstad Hospital, Maxima Medical Center, Reinier de Graaf Groep, Erasmus Medical Center, Merck Sharp & Dohme LLC, Zuyderland Medical Centre, Haga Hospital
Conditions Immune System Disorder, Preterm, Vaccination Failure
Enrollment 145 participants
Start Date 2022-12-08
Primary Completion 2025-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2024-03-20