Skip to main content
Clinical Trials/NL-OMON56341
NL-OMON56341
Recruiting
Not Applicable

Preterm Immune system development and response to Immunization - Primi study

kindergeneeskunde0 sites265 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
respons op vaccinaties
Sponsor
kindergeneeskunde
Enrollment
265
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
kindergeneeskunde

Eligibility Criteria

Inclusion Criteria

  • Preterm infant born at gestational age less than 32 weeks (whose mothers did
  • or did not receive a T dap vaccination during pregnancy) OR healthy full\-term
  • infant whose mother received a Tdap vaccination during pregnancy
  • Mothers of included preterm infants
  • Parents/ guardians must have sufficient understanding of the Dutch language

Exclusion Criteria

  • Parents/guardians 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
  • Infant with a (possible) HIV infection, immunodeficiency or use of
  • immunomodulating drugs
  • Maternal use of immunosuppressive drugs during pregnancy
  • Parental intention not to vaccinate according to the National Immunization

Outcomes

Primary Outcomes

Not specified

Similar Trials