Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age. - MIKI

RIVM0 个研究点目标入组 224 人开始时间: 2013年9月9日最近更新: 2020年10月26日

试验速览

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•Pregnant women 18-40 years of age
•Women with a low risk of pregnancy complications as assessed by a midwife/obstetrician/gynaecologist with a normal 20 weeks ultrasound of the fetus
•Women who are willing to adhere to the protocol and perform all planned visits and sample collections for themselves and their newborn child
•Parents have to be willing to have their infant vaccinated with the hexavalent (DaKTP-Hib-Hep) vaccine at 3, 5 and 11 months of age according to the described procedures
•Presence of a signed informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 112
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 112
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Pregnant Woman:
•History of having received a pertussis vaccination in the past 5 years
•-History of having received a TD containing vaccine in the past 2 years
•-Known or suspected serious underlying condition that can interfere with the results of the study such as but not limited to cancer, autoimmune disease, immunodeficiency, seizure disorder or significant psychiatric illness
•-Receipt of any high-dose (= 20 mg of prednisone daily or equivalent) daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry
•-Receipt of other immune modulating medication, for instance biologicals
•-Receipt of blood products or immunoglobulin, within three months of study entry (Rhesus negative women who receive antirhesus (D)- immunoglobuline will not be excluded from the trial)
•-Presence of bleeding disorder
•-Having experienced a previous severe adverse reaction to any vaccine
•-Receipt of any vaccine(s) within 2 weeks of study vaccine (except influenza vaccine which may be given concomitantly)
•-History of febrile illness (>38.0°C orally) within the past 72 hours (immunization may be deferred)
•Exclusion criteria for newborns of participating mothers:
•Serious underlying medical condition that can interfere with the results of the study
•Premature infants born before 37 weeks gestational age

发起方

RIVM