EUCTR2022-002697-80-BE进行中（未招募）1 期
Maternal determinants of infant immunity to pertussis - MADI-02
niversité Libre de Bruxelles0 个研究点目标入组 240 人开始时间: 2022年9月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- 性别
- All
入选标准
- •1.Eligibility of pregnant and non-pregnant women
- •-Age between 18 and 45 years
- •-Eligible for Tdap vaccination
- •-Last Pertussis vaccination < 12 months ago
- •- Consent form signed
- •2.Eligibility of infants:
- •-Infants of 2 months (+- 1 week) of age (boys and girls)
- •-Born after 35 weeks of gestation
- •-Birthweight above 2.5 kg
- •-Consent form signed by the parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Exclusion criteria (non-pregnant women and pregnant women):
- •-Inability to understand the nature and extent of the study and the procedures required
- •-Grade III/IV anemia,
- •-Acute infection at the time of immunization
- •-Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
- •-Current or recent use of immunosuppressive drugs
- •-Active neoplasia
- •-Other vaccination at the same time as pertussis vaccination
- •Specific to pregnant women:
- •-Risk of premature delivery or intrauterine growth retardation
- •-Twin or triplet pregnancies
- •2. Exclusion criteria (infants):
- •-Severe neonatal distress
- •-Serious congenital abnormalities or congenital infection.
研究者
相似试验
已完成
4 期
Maternal Determinants of Infant Immunity to PertussisMaternal-Fetal RelationsImmunoglobulinsInfection VaccinationPertussisNCT05856396Centre Hospitalier Universitaire Saint Pierre200
已完成
4 期
*Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?*whooping coughpertussisNL-OMON49737RIVM6,750
进行中（未招募）
不适用
Maternal antibodies against pertussis in neonates .Pertussis disease is reported in very young children who have not yet been (fully) vaccinated and did not receive sufficient maternal antibodies. Augmenting maternal antibody titers by administering a prepregnancy booster in women is investigated as a way to protect young children.EUCTR2010-023976-16-BEniversity of Antwerp
进行中（未招募）
1 期
‘Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?women in their first trimester of pregnancyEUCTR2018-002976-41-NLRIVM120
尚未招募
4 期
A study on the maternal and infant factors determining the performance of Rotavirus vaccines in African, Indian and European infants.CTRI/2015/11/006354Christian Medical College385