EUCTR2018-003451-38-GB进行中（未招募）1 期
Immunogenicity and reactogenicity of concomitantly administered hexavalent and Group B meningococcal vaccines in infancy. - The 6-in-1 Vaccine Study
Clinical Trials and Research Governance (CTRG)0 个研究点目标入组 240 人开始时间: 2019年1月31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 clinical trial of medicinal product
入排标准
入选标准
- •For recruitment to all study groups, participants MUST FULFILL each of the below criterion:
- •Parents/legal guardians are over 16 years of age, and are willing and able to consent to enrol their child/children in the study
- •Parents/legal guardians able comply with the requirements of the trial protocol and have internet access for the duration of the study
- •Parents/legal guardians are willing to allow their General Practitioner, health visitor and consultant, if appropriate, to be notified of participation in the trial.
- •Participants born at greater than or equal to 37 weeks gestation
- •Participants are due to receive their primary immunisations, aged 8 to 13 weeks (i.e. the day the child turns 13 weeks of age) at enrolment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 240
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The participant may not enter the trial IF ANY of the following apply:
- •Parents/legal guardians of children are on the delegation log of this study
- •Confirmed or suspected immunodeficiency
- •Fulfil any of the contraindications to vaccination as specified in The Green Book
- •Confirmed anaphylactic reaction/s to any constituent/s or excipient/s of the vaccine(s)
- •Confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine), kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the Meningococcal B vaccine) or to gelatin (which may be present in trace amounts in the MMR vaccine)
- •Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine Bexsero may contain natural rubber latex)
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
- •Thrombocytopenia or any other bleeding disorders.
- •Child is currently participating in another interventional clinical trial
- •Temporary exclusions for all groups
- •For a vaccination visit only (visit 1, 2, 3, and 5)
- •Administration of any other vaccine within 14 days prior to study vaccines.
- •Scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving a vaccine
- •Febrile illness (axillary temperature =38.0°C) within the previous 24 hours or on the day of vaccination
- •For a blood sampling visit only (visit 4 and 6)
- •Have received parenteral or oral antibiotics within the last 7 days
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