A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with COVAXINÂ®, and to assess Lot to Lot Consistency of BBV154 in Healthy Volunteers

Bharat Biotech International Limited14 个研究点分布在 1 个国家目标入组 3,160 人开始时间: 2022年2月15日最近更新: 2023年5月26日

试验速览

阶段: 3 期
状态: 已完成
发起方: Bharat Biotech International Limited
入组人数: 3,160
试验地点: 14
主要终点: (NAbâ€™s) by neutralizing antibody

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with COVAXINÂ®, and to assess Lot to Lot Consistency of BBV154 in Healthy Volunteers.

Study Design:

A total sample size of 3160 healthy volunteerâ€™s ageâ€™s â‰¥18 years will be recruited in this study.

Group 1 (BBV154): In this group, 3000 participants will be recruited, randomized in 1:1:1 ratio receive 3 consecutive lots (Lot 1: 1000, Lot 2: 1000, Lot 3: 1000) of the BBV154 vaccine (0.5 mL each dose) on day 0 and day 28 via intranasal route.

Group 2 (COVAXINÂ®): In this group, 160 participants will be recruited and administered with COVAXINÂ® vaccine on day 0 and on day 28 via intramuscular route.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Ability to provide written informed consent.
•Participants of either gender of age â‰¥18 years.
•Good general health as determined by the discretion of investigator (vital signs : (heart rate â‰¥60 toâ‰¤100 bpm; blood pressure systolic â‰¥90 mm Hg and <140 mmHg; diastolic â‰¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ÂºF), medical history, and physical examination).
•Expressed interest and availability to fulfil the study requirements.
•For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination.
•Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination
•Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after last vaccination
•Agrees not to participate in another clinical trial at any time during the study period.
•Agrees to remain in the study area for the entire duration of the study.
•Willing to allow storage and future use of biological samples for future research.

排除标准

•History of any other COVID-19 investigational/or licensed vaccination.
•For women of child bearing potential, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine).
•Temperature >38.0Â°C (100.4Â°F) or symptoms of an acute self limiting illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
•Medical problems because of alcohol or illicit drug use during the past 12 months.
•Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period.
•Receipt of any licensed vaccine within four weeks before enrolment in this study.
•Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
•Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
•Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
•Long-term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
•Any history of anaphylaxis in relation to vaccination.
•History of any cancer.
•History of severe psychiatric conditions likely to affect participation in the study.
•A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture).
•Any other serious chronic illness requiring immediate hospital specialist supervision.
•Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.