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.
Investigators
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
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