ACTRN12624000294550尚未招募3 期
Randomized Controlled Trial of COVID-19 booster vaccine for intramuscular versus subcutaneous administration assessing immunogenicity and reactogenicity. in pharmacies/vaccination sites in Aotearoa, New Zealand.
Medical Research Institute of New Zealand (MRINZ)0 个研究点目标入组 486 人开始时间: 2024年3月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 486
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
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1.Adult aged 18 – 75 years.
- •2.BMI cutoff points will be determined by sex assigned at birth. Female with BMI >30.2 kg/m2 or male with BMI >37.3 kg/m2
- •3.Have received at least 2 previous COVID-19 vaccinations.
- •4.Be eligible to receive Pfizer Comirnaty COVID-19 booster vaccine.
- •5.Participant must be willing and able to provide written informed consent.
- •6.Access to a mobile phone and/or device with internet connectivity to complete remote diary entries and surveys.
- •7.Willing and able to comply with the study instructions.
排除标准
- •1.Positive COVID-19 infection within 6 months prior to screening.
- •2.Received COVID-19 vaccination within 6 months prior to screening.
- •3.History or anaphylaxis, allergic disease, severe reactions to COVID vaccine, or reaction likely to be exacerbated by any component or study participation.
- •4.Cognitive impairment that prevents the participant from understanding the study instructions, completing questionnaires, or providing informed consent.
- •5.Is acutely ill or febrile 72 hours prior to or at vaccination visit. Fever is defined as a body temperature greater than 38.0°C.
- •6.Individuals receiving treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planes receipt throughout the study. If systemic corticosteroids have been administered short term for treatment of acute illness, participants should not be enrolled into study until corticosteroid therapy has been discontinued for at least 28 days before study vaccine is administered. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- •7.Any contraindication to IM, SC injections or blood tests including but not limited to bleeding disorders.
- •8.Is pregnant.
- •9.Has received or plans to receive immunoglobulins or any blood products within 3 months before the study vaccination through to the end of the study.
- •10.Has received or plans to receive any non-study vaccinations within 14 days prior to screening or 28 days after dose of study vaccine.
研究者
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