ISRCTN15638344已完成2 期
A single-blind, randomised, phase II study to determine safety and immunogenicity of the Coronavirus Disease (COVID-19) vaccine ChAdOx1 in UK healthy children and adolescents (aged 6 - 17 years)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 262
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35691324/ (added 13/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy child or adolescent aged 6-17 years (upper age limit is 17 years and 8 months so that both prime and booster are expected to take place prior to their 18th birthday)
- •2. Able and willing (in the Investigator’s opinion) to comply with all study requirements (participant’s parents/guardians must not rely on public transport or taxis)
- •3. Willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures
- •4. Parent/guardian to provide informed consent for participants under the age of 16; it will be assumed that participants aged 16 and over are able to provide consent for themselves, however parental support will be sought and investigators will reserve the right to refuse enrollment if concerns arise
排除标准
- •1. History of laboratory confirmed COVID-19 (A positive result on a validated test for SARS-CoV-2 or seropositivity for SARS-CoV-2 before enrolment)
- •2. Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)
- •3. Prior receipt of MenB vaccine
- •4. Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment
- •5. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
- •6. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines)
- •7. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- •8. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days)
- •9. Any autoimmune conditions,
- •10. History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenB vaccines
- •11. Previous diagnosis of Kawasaki disease
- •12. Any history of angioedema
- •13. Any history of anaphylaxis
- •14. Pregnancy, lactation or willingness/intention to become pregnant during the study
- •15. Any history of cancer
- •16. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •17. Any other serious chronic illness requiring hospital specialist supervision
- •18. Congenital cardiovascular conditions
- •19. Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data
- •20. Child of a staff member of the Oxford Vaccine Group
研究者
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