drugset / Trial / NCT02408926

Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand

NCT02408926

RandomizedParallel-groupOpen-labelPrevention

Summary

Young infants are most vulnerable to severe disease and even death when infected with Bordetella pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates from this disease. Maternal acquired pertussis-specific antibodies show low concentrations with short persistence in newborns creating a susceptibility gap for infection between birth and the first vaccinations. A possible strategy to protect infants from birth is pertussis vaccination during pregnancy, which will increase the amount of passively transferred maternal antibodies. However, little is known regarding the effect of high titers of maternal antibodies on the infants immune responses to different pertussis vaccines (whole cell versus acellular). Humoral immune responses will be assessed in infants receiving whole cell versus infants receiving acellular pertussis vaccines. Functionality of the antibodies will also be analyzed.

Timeline

Start
2015-04
Primary completion
2018-08
Completion
2018-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Infanrix hexa Vaccine
Comparator Quinvaxem Vaccine
Background Boostrix Vaccine
Comparator OPV Vaccine

Indications