EUCTR2011-001936-45-BE进行中（未招募）不适用
Pertussis vaccination in pregnancy - matab4
未提供0 个研究点开始时间: 2011年4月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria
- •-Women aged 18-35 years
- •-Willing to be immunized during pregnancy
- •Received already a pertussis vaccination during pregnancy, as advised by gynaecologist or general practitioner.
- •-Age matched controls will be identified in the same time period in the recruiting hospital.
- •-Intend to be available for follow-up visits and phone call access through 16 months following delivery
- •-Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15 months of age (= normal Belgian schedule) with pediatrician, the general practitioner or at the Centre for the Evaluation of Vaccination.
- •-In the 18th-32nd week of a pregnancy at low risk for complications as determined by the obstetrician and some of the following criteria:
- •1.Second trimester ultrasound with no significant abnormalities
- •2.No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis)
- •3.Pregnancy estimated to be at low risk (< 1 / 300) for Down's syndrome (trisomy 21), trisomy 13 and trisomy 18 tested at 11-13 weeks of gestation. Appropriate screening test includes any one of the following:
- •a.second trimester screening based on
- •i.nuchal translucency measurement,
- •ii.pregnancy-associated serum protein A (PAPP-A) and free beta- human chorionic gonadotropin (ß-HCG)
- •taking into account maternal age and pregnancy duration
- •b.first trimester ultrasound screening and second trimester maternal serum screening test that looks for four specific substances: AFP, total HCG, Estriol (and Inhibin-A), with risk estimated using an integrated, sequential, or contingency approach, and taking into account maternal age
- •c.second trimester maternal serum screening test that looks for four specific substances: AFP, total hCG, Estriol (and Inhibin-A)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A. Pregnant women
- •-Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- •-Significant mental illness (e.g. schizophrenia, psychosis, major depression)
- •-History of a febrile illness (greater than or equal to 38° Celsius) within the past 72 hours before injection
- •-Previous severe reaction to any vaccine
- •-Receipt of tetanus-diphtheria toxoid immunization within the past 2 years
- •-Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization in the last 10 years
- •-Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to injection through 4 weeks following injection
- •-Receipt of or plans to receive influenza vaccine within the 2 4weeks prior to or following injection. One month interval should be respected in order to evaluate eventual Adverse events following one of both vaccines (fever, local symptoms).
- •-Deemed high risk for serious obstetrical complication
- •-Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk
- •B.Children with following criteria
- •-Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- •-No signed informed consent by both parents
- •-Severe reactions to any vaccine
- •-Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
研究者
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