跳至主要内容
临床试验/2024-510787-23-00
2024-510787-23-00招募中4 期

Maternal pertussis immunization in Finland, 4 years (MIFI-4Y)

Varsinais-Suomen hyvinvointialue1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2024年4月30日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
138
试验地点
1
主要终点
PT-specific IgG antibody geometric mean concentration (GMC) at 4 years+28 days in children from Arm 1 versus Arm 2.

研究概览

简要总结

Aim of the study is to investigate the possible long-lasting differences in the pertussis immunity between the children whose mothers were vaccinated during pregnancy and control children at the age of 48 months.

入排标准

年龄范围
0 years 至 64 years(18-64 Years, 0-17 Years)
接受健康志愿者

入选标准

  • Participation and completion of the 6-month timepoint in the original MIFI study will be the only inclusion criterion.

排除标准

  • The exclusion criteria include decline from or clinical conditions that disallow the study procedures.

结局指标

主要结局

PT-specific IgG antibody geometric mean concentration (GMC) at 4 years+28 days in children from Arm 1 versus Arm 2.

PT-specific IgG antibody geometric mean concentration (GMC) at 4 years+28 days in children from Arm 1 versus Arm 2.

次要结局

未报告次要终点

研究者

发起方
Varsinais-Suomen hyvinvointialue
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Lauri Ivaska

Scientific

Varsinais-Suomen hyvinvointialue

研究点 (1)

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