ACTRN12619000792123终止3 期
A Phase IIIb-IV, Multicentre, Randomised, Open-label Study to Characterise the Reactogenicity of Afluria Quad Junior in Children 6 Months to Less Than 3 Years, and Afluria Quad in Children 3 Years to Less Than 9 Years Across Three Influenza Seasons
Seqirus0 个研究点目标入组 1,056 人开始时间: 2019年5月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,056
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Months 至 8 Years（—）
- 性别
- All
入选标准
- •1. Male or female subjects 6 months to less than 9 years of age at the time of planned first vaccination in a given season;
- •2. Subjects whose parent(s)/guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry and are willing and able to adhere to all protocol requirements.
排除标准
- •1. History of severe allergic reactions (eg, anaphylaxis) to any component of the Study
- •Vaccine or to a previous dose of any influenza vaccine.
- •2.Participant has received a licensed or investigational influenza vaccine in the 6 month period prior to enrolment.
- •3. Family members of the employees of the Investigator or study centre with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study centre.
- •4. Any other condition that per the opinion of the investigator may adversely impact the subject through participation in the study.
研究者
相似试验
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsSCLCEUCTR2021-004606-21-HUAstraZeneca AB1,000
招募中
3 期
Study of Datopotamab Deruxtecan (Dato-DXd) for first line treatment of patients with locally advanced or metastatic NSCLCCTRI/2023/05/052218AstraZeneca AB
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)SCLCEUCTR2021-004606-21-ATAstraZeneca AB1,280
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsSCLCEUCTR2021-004606-21-DEAstraZeneca AB1,280
进行中（未招募）
1 期
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic AlterationsSCLCMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-004606-21-BGAstraZeneca AB1,280