EUCTR2020-003466-39-BE进行中（未招募）1 期
Pertussis immunization during pregnancy: assessment of the role of maternal antibodies on immune responses in term and preterm infants (the MAMA study) - the MAMA study
niversity of Antwerp0 个研究点目标入组 300 人开始时间: 2021年7月29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
- 300
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
- •I.Female population older than 18 Years
- •II.Women in the vaccinated cohort: received a pertussis containing vaccine (paper-proven) during pregnancy within the present Belgian recommendation. They will not receive the vaccine within the study.
- •III.Women in the unvaccinated cohorts: received no pertussis containing vaccine at least 5 year before study entrance, but can receive a vaccine in postpartal period. The cocoon strategy has to be taken into account in the analysis of breast milk samples.
- •IV.Intend to be available for follow-up visits and phone call access through 16 months following delivery.
- •V.Willing to have infant immunized with hexavalent vaccine according to the general Belgian schedule.
- •VI.Influenza vaccination during pregnancy is allowed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for women (limited since premature delivery is usually the result of serious events):
- •Pregnant women who meet any exclusion criteria at baseline will be excluded from the study.
- •I. Significant mental illness (e.g. schizophrenia, psychosis, major depression)
- •II. Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection)
- •III. Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
- •IV. Receipt of a blood product or experimental medicine within 4 weeks prior to delivery or prior to blood sampling. Exclusion for 1 time point is possible after blood transfusion, with reboot of the study 1 month after transfusion.
- •Exclusion criteria for children:
- •I. No signed informed consent from both parents.
- •II. Severe reactions to any vaccine.
- •III. Serious underlying medical condition (e.g., genetic disorder (eg Down syndrome), immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- •IV. Children suffering from primary humoral immune disorders (B cell related): severe X linked agammaglobulinaemia, CVID (Common variable immunodeficiency, late onset agammaglobulnaemia) and SAD (specific antibody deficiency); suffering from primary cellular immune deficiencies (T cell related): SCID (Severe combined immune deficiency syndrome), CID, hyper IGM syndrome, di George's syndrome and others;
- •suffering from disorders in phagocytosis and chemotaxis (CGD, Schwach Diamond syndrome) and disorders from the complement cascade.
- •V. In addition, children on immunodepressive medication and with hemato-oncologic disorders will be excluded. All these children can receive the inactivated pertussis vaccines, but will respond different from the normal population to vaccination.
- •VI. Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
- •VII. Receipt of a blood product 1 month prior to blood sampling. Exclusion for 1 time point is possible after blood transfusion, with reboot of the study 1 month after transfusion.
研究者
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