EUCTR2013-004495-34-GB进行中（未招募）1 期
A randomised controlled trial comparing two pertussis-containing vaccines in pregnancy and vaccine responses in UK mothers and their infants (immunising Mums Against Pertussis, iMAP2) - iMAP2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
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
入选标准
- •Pregnant women who, at the time of enrolment
- •are aged 16- 45 years
- •Infants of the women recruited will also be seen during the study. They will be given their immunisations according to the routine childhood immunisation schedule and will have blood samples collected as detailed in the clinical procedures section of this form. Their inclusion/ exclusion will be as per the Green Book recommendations by the UK Dept of Health.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Participants may not be included in the study if any of the following apply:
- •Bleeding disorder
- •Receipt of any pertussis containing vaccine in the previous 12 months
- •Women to be vaccinated only (i.e. not the control group):
- •Received immunoglobulin or other blood product within the preceding 3 months
- •Fulfil any of the contraindications to vaccination specified in The Green Book on Immunisation (https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book), including:
- •Õ A confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine
- •ÕA confirmed anaphylactic reaction to any component of the vaccine
- •ÕA confirmed anaphylactic reaction to a previous dose of diphtheria, tetanus, pertussis or poliomyelitis containing vaccine
- •Temporary Exclusion Criteria
- •If the pregnant woman or the baby has an axillary/aural temperature = 38°C, then vaccination and blood sampling will be postponed until resolution of fever. If the pregnant woman or baby is acutely unwell, vaccination will postponed until resolution. Blood sampling will also be postponed for seven days after completion of any antibiotic course.
- •Infants will be vaccinated under the routine national immunisation schedule in accordance with the inclusion/ exclusion criteria set out in the Department of Health Green Book
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