Pertussis vaccine
BiologicalVaccination during pregnancy with a pertussis containing vaccine
Other names: Boostrix®, GSK Biologicals, Rixensart
NCT Number: NCT01698346
Despite good vaccination coverage, included in national immunization programs in developed countries, the number of reported pertussis cases is rising, also in very young infants. Current immunization strategies fail to protect infants too young to be immunized with the licensed vaccine. Different strategies are possible to close the gap of susceptibility between the loss of maternal antibodies and protection by vaccination. The main aim of the present study is to measure the influence of an adult pertussis booster in pregnant women, on the titer and duration of maternal antibodies in their infants. Early humoral immunity will be assessed and the influence on vaccine response of the infant measured. The present study offers the opportunity to have new insights in neonatal immunological mechanisms against pertussis and a better understanding in strategies to protect infants against pertussis.
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Notify Me18 year–40 year
Female
Interventional
Phase 4
Centre for the Evaluation of Vaccination, Antwerp, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women:
Exclusion criteria
for the offspring:
Vaccination during pregnancy with a pertussis containing vaccine
Other names: Boostrix®, GSK Biologicals, Rixensart
Time frame: 16 months
Time frame: 16 months
Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
Time frame: 16 months
Infant growth measurement at all time points
Time frame: 12 months
The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.
Universiteit Antwerpen
Other
Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants
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