2024-515122-89-00招募中4 期
An open-label pilot study to assess pain experience and usability of different injection techniques and devices for the administration of the purified chick-embryo cell-culture rabies vaccine in children aged 4 to 14 years
Institute Of Tropical Medicine1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年10月21日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The mean and median score of the Faces Pain Scale-Revised (FPS-R) after each vaccination. The FPS-R is a validated scoring system for the assessment of acute pain in children from 4 years onwards
研究概览
简要总结
To estimate the pain intensity experienced by the child after each vaccination.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 4 and ≤ 14 years at time of informed consent
- •Parent/legal guardian is willing to provide written informed consent, thereby confirming the other parent/legal guardian is aware of the trial and agrees with the child’s participation
- •Preparedness to follow the study schedule
- •One or more expected travel(s) to (a) rabies endemic countr(y)(ies), for which the (cumulative) risk is evaluated as high for rabies exposure and therefore is an indication to receive rabies PrEP.
排除标准
- •Any vaccination against rabies (memorised or stated in the vaccination certificate)
- •Any planned travel from the day of screening until 15 days after receiving the third dose of the study vaccine to rabies endemic countries which is evaluated as high risk for rabies exposure and therefore is an indication to receive standard rabies PrEP
- •History of extreme fear for injections, to this extent that it would be impossible to safely and child-friendly administer the study vaccine
- •History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine
- •Immunocompromised participants or participants who take immunosuppressive medication
- •Known coagulation disorder contra-indicating intramuscular vaccinations
- •History of or planned vaccination with an inactivated or live attenuated vaccine ≤ 14 days prior to or ≥ 14 days after each trial vaccination
- •Participation in another investigational study at the time of informed consent
结局指标
主要结局
The mean and median score of the Faces Pain Scale-Revised (FPS-R) after each vaccination. The FPS-R is a validated scoring system for the assessment of acute pain in children from 4 years onwards
The mean and median score of the Faces Pain Scale-Revised (FPS-R) after each vaccination. The FPS-R is a validated scoring system for the assessment of acute pain in children from 4 years onwards
次要结局
- The mean and median score of a Numeric Rating Scale (NRS), as judged by the parent/legal guardian after each vaccination.
- The mean and median score of a NRS for each aspect of the usability parameters ‘ease of use’ and ‘safety’.
- Percentage of participants that have rabies antibodies ≥ 0.5 IU/ml on day 28 after the third dose of study vaccine. A titre ≥ 0.5 IU/ml is defined as an adequate seroconversion after vaccination according to WHO standard.
- Count and percentage of solicited and unsolicited AEs up to day 7 after each vaccination. Categories: mild, moderate, severe.
- Count and percentage of related and unrelated MAAEs resulting in study discontinuation and SAEs throughout the study period.
- The mean and median score of the Children’s Fear Score (CFS) after each vaccination.
研究者
Patrick Soentjens
Scientific
Institute Of Tropical Medicine
研究点 (1)
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