NL-OMON44971已完成4 期
Maternal pertussis (Tdap) vaccination and its effects on the immune response of the newborn up to 12 months of age. - Effects of maternal pertussis vaccination on infant immune response
RIVM0 个研究点目标入组 353 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 353
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •* 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
排除标准
- •Exclusion criteria for (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 partners or other primary caregivers:
- •- Having experienced a previous severe adverse reaction to any vaccine
- •- History of febrile illness (>38.0*C orally) within the past 72 hours (immunization may be deferred) ;Exclusion criteria for new-borns of participating mothers:
- •- Serious underlying medical condition that can interfere with the results of the study
- •- Premature infants born before 37 weeks gestational age
研究者
相似试验
进行中（未招募）
1 期
The effects of Pertussis vaccination of pregnant woman on the production of antibody's in the blood of newborns up to 12 months of ageEUCTR2013-003090-98-NLRIVM224
已完成
4 期
Effects of maternal pertussis vaccination on infant immune response<p>Maternal Vaccination Pertussis Boostrix</p>10004018NL-OMON22463ational Institute of Public Health and theEnvironment (RIVM)118
已完成
4 期
Vaccine responses in infants after acellular pertussis vaccination during pregnancy in ThailandInterference of maternal antibodies on infants immune responsesacellular vaccinewhole cell pertussis vaccineantibody responsescellular immune responsespertussisTCTR20180926001The Thrasher Research Fund370
进行中（未招募）
不适用
Vaccination against whooping cough in pregnancyEUCTR2011-001936-45-BE
进行中（未招募）
1 期
Maternal pertussis Immunization in FInland Study - MIFI StudyPertussis InfectionMedDRA version: 20.0Level: PTClassification code 10034738Term: PertussisSystem Organ Class: 10021881 - Infections and infestationsEUCTR2019-001986-34-FITurku University Hospital160