CTRI/2024/01/061423进行中（未招募）3 期
A prospective single-blind randomized phase-III comparative study to evaluate immunogenicity and safety of Biological E’s XBB.1.5-RBD subunit Covid-19 vaccine in 5-80 years old individuals.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 7
- 主要终点
- 1. Immune response measured as determined by geometric mean titre (GMT) of anti-XBB.1.5.RBD neutralizing antibodies
研究概览
简要总结
This will be a prospective, multicentre, single-blind, randomised, comparative phase III clinical study to evaluate the immunogenicity and safety of two booster doses of Biological E’s XBB.1.5-RBD subunit vaccine, when administered in to individuals ≥5 to ≤80 years of age previously vaccinated with any existing COVID-19 vaccine either as primary series or booster dose with the most recent dose at least six months prior to enrolment.
A total of 360 subjects, aged 5 to 80 years, will be enrolled to either test group (Group-1) or to control group (Group-2) for immunogenicity and safety assessment.
All eligible subjects will be randomised by treatment planned and by age into respective arms.
The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to provide written informed consent and by the subjects or their parents or legally acceptable representative and also an assent by the children aged between 7 to 18 years
- •Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol
- •Participants of either gender, aged between 5 to 80 years on the day of screening
- •Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR prior to enrolment.
- •5.Participants who have not received any COVID-19 related vaccine(s), during the last six months prior to enrolment 6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital sign as defined in the protocol.
- •Subject or his or her LAR agrees not to participate in another clinical trial at any time during the total study period.
- •8.Subject or his or her LAR willing to allow storage and future use of collected biological samples for future research in an anonymised form.
- •9.Subject or his or her LAR agrees to remain in the town where the study centre is located, for the entire duration of the study.
排除标准
- •Living in the same household of any COVID-19 positive person;
- •Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
- •History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
- •Current or planned participation in prophylactic or therapeutic drug trials for the duration of the study.
- •5.Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.;
- •Pregnant women, nursing women or women of childbearing potential who are or may not actively avoid pregnancy during the study period;
- •Chronic respiratory disease, including asthma;
- •Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
- •Individuals who are part of the study team or close family members of individuals conducting the study.
- •Anaphylactic reaction following administration of the investigational vaccine.
- •History of severe psychiatric conditions likely to affect participation in the study;
- •History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
- •History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s test or control vaccine formulations;.
结局指标
主要结局
1. Immune response measured as determined by geometric mean titre (GMT) of anti-XBB.1.5.RBD neutralizing antibodies
时间窗: 1. At day 28 and at day 42 in cohorts under Group-1 (test) and Group-2 (control)
次要结局
- Occurrence of any adverse reactions(Within 60 minutes of immediate post vaccination period)
- Occurrence of any solicited adverse events(Within 7 consecutive days after each dose)
- Occurrence of any unsolicited adverse events (AEs), serious AEs (SAEs), medically attended AEs (MAAEs) or AEs of special interest (AESIs) in all study participants(until 28 days’ post vaccination period)
- To assess geometric mean titre (GMT) of, Anti-XBB.1.5-RBD-IgG and PSVNT antibodies(At baseline, Day-28 and Day-42 time-points in both test (Group-1) and control (Group-2) groups)
- To assess geometric mean fold rise (GMFR) in Anti-XBB-1.5 RBD-IgG and PSVNT antibodies(From baseline at day 28 and again at day 42 in both test (Group-1) and control (Group-2) groups)
- Proportion of subjects with ≥2-fold and ≥4-fold rise(At day 28 and day 42)
研究者
Dr Subhash Thuluva
Biological E.Limited
研究点 (7)
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