EUCTR2021-003591-13-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
- •- Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Known allergy to any vaccine component
- •- History of severe allergic reaction that required medical intervention
- •- Thrombocytopenia or any coagulation disorder
- •- Has a history of myocarditis or pericarditis
- •- Has a history of a clinical or microbiological diagnosis of COVID-19 =90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
- •- Females only: participant is pregnant
- •- Currently immunocompromised, or been diagnosed with immunodeficiency
- •- Had a splenectomy
- •- Receiving or has received immunosuppressive therapies within the last year
- •- Received any immunoglobulin product or blood-derived product within 3 months
- •- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
研究者
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