Preterm Immune System Development and Response to Immunization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-2
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)
Parents/ guardians must have sufficient understanding of the Dutch language
healthy full-term infant whose mother received a Tdap vaccination during pregnancy
Parents/ guardians must have sufficient understanding of the Dutch language
Disqualifiers
Parents/guardians of the infant are not able or willing to provide informed consent
Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)
Infant with a (possible) HIV infection or immunodeficiency
Maternal use of immunosuppressive drugs during pregnancy
Trial design
Treatments tested in this trial
- Not listed
Trial groups
145 Participants
are grouped into 2 trial groupsSponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Medical Center Haaglanden
Collaborator
Amphia Hospital
Collaborator
Albert Schweitzer Hospital
Collaborator
Franciscus Gasthuis
Collaborator
Maasstad Hospital
Collaborator
Maxima Medical Center
Collaborator
Reinier de Graaf Groep
Collaborator
Erasmus Medical Center
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Zuyderland Medical Centre
Collaborator
Haga Hospital
Collaborator
Source ClinicalTrials.gov