A Phase III, Parallel Group, Prospective, Randomized, Double-blind, Active-controlled, Two-arm, Multi-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of MVC-COV1901 Compared to AZD1222 in Adults of 18 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,030
- 试验地点
- 2
- 主要终点
- Immunogenicity of neutralizing antibody (GMT ratio)
研究概览
简要总结
The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
详细描述
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participant aged 18 years and above at randomization.
- •Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
- •Female participants:
- •A female participant is eligible is the participant is a woman of non-childbearing potential, ie, surgically sterilized or one year post-menopausal.
- •If the participant is a woman of childbearing potential, she must agree to practice sexual abstinence or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention.
- •Have a negative pregnancy test
- •Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
- •Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
排除标准
- •Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
- •Employees at the investigator's site, of the Sponsor or delegate who are directly involved in the conduct of the study.
- •Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
- •Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
- •Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
- •Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy within 12 weeks prior to the first dose of study intervention.
- •Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors within 12 weeks prior to the first dose of study intervention.
- •Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
- •Has received any other investigational or approved COVID-19 vaccine.
- •Immunosuppressive illness or immunodeficient state.
- •A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer.
- •Bleeding disorder considered a contraindication to IM injection or phlebotomy.
- •Known SARS-CoV-2 infection in the 3 months prior to the first dose of study intervention.
- •A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- •Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint.
- •A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901 or AZD
- •Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness within 2 days before the first dose of study intervention.
结局指标
主要结局
Immunogenicity of neutralizing antibody (GMT ratio)
时间窗: Day 1 to Day 43
To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination -GMT ratio
Incidence of Adverse Event within 28 days post the second study intervention
时间窗: Day 1 to Day 57
To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination The number and percentage of participants with the occurrence of: * Solicited local AEs * Solicited systemic AEs * Unsolicited AEs * Medically attended AEs (MAAEs) * AESIs * VAED * SAEs
次要结局
- Immunogenicity of neutralizing antibody(GMT ratio)(Day 29 to Day 209)
- Incidence of Adverse Event throughout study conduct(Day 1 to 180 days after second vaccination)
- Immunogenicity of neutralizing antibody (GMT)(Day 29 to Day 209)
- Immunogenicity of neutralizing antibody(SCR)(Day 29 to Day 209)