Preterm Immune system development and response to Immunizatio
- Conditions
- respons op vaccinatiesimmune system of preterm born infantsresponse to vaccination1002146010019815
- Registration Number
- NL-OMON56341
- Lead Sponsor
- kindergeneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 265
• 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
• 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
defect)
• 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
Program
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To measure blood IgG antibody concentrations against the antigen components of<br /><br>the hexavalent DTaP5-HB-IPV-Hib vaccine for the six preventable diseases<br /><br>(Diphtheria, Tetanus, Pertussis, Polio, Hepatitis-B, Haemophilus influenza type<br /><br>B) in preterm-born infants 4- 6 weeks after primary series of routine<br /><br>vaccinations in order to assess the proportion of children with IgG<br /><br>concentrations above international-defined thresholds for protection. This<br /><br>proportion will be compared with proportions in healthy term infants as known<br /><br>from literature. . </p><br>
- Secondary Outcome Measures
Name Time Method