Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Inclusion Criteria ONLY for Phase II: <br/ >1.Male or female (non-pregnant) subject between â?¥ 18 to 55 years of age. <br/ >2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment. <br/ >Inclusion Criteria ONLY for Phase III: <br/ >1.Male or female subject between â?¥ 18 to 80 years of age. <br/ >Inclusion Criteria for Phase II and Phase III: <br/ >1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study. <br/ >2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment. <br/ >4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ >6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ >7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ >8.Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Subject agrees to refrain from blood donation during the course of the study. <br/ >10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ > <br/ > <br/ >

Inclusion Criteria ONLY for Phase II: <br/ >1.Male or female (non-pregnant) subject between â?¥ 18 to 55 years of age. <br/ >2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment. <br/ >Inclusion Criteria ONLY for Phase III: <br/ >1.Male or female subject between â?¥ 18 to 80 years of age. <br/ >Inclusion Criteria for Phase II and Phase III: <br/ >1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study. <br/ >2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment. <br/ >4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ >6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ >7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ >8.Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Subject agrees to refrain from blood donation during the course of the study. <br/ >10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ > <br/ > <br/ >

Nov. 13, 2021, 5:33 p.m. oms

Sept. 8, 2021, 1:30 a.m. oms

Inclusion Criteria ONLY for Phase II: <br/ >1.Male or female (non-pregnant) subject between â?¥ 18 to 55 years of age. <br/ >2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment. <br/ >Inclusion Criteria ONLY for Phase III: <br/ >1.Male or female subject between â?¥ 18 to 80 years of age. <br/ >Inclusion Criteria for Phase II and Phase III: <br/ >1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study. <br/ >2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment. <br/ >4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ >6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ >7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ >8.Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Subject agrees to refrain from blood donation during the course of the study. <br/ >10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ > <br/ > <br/ >

Inclusion Criteria ONLY for Phase II: <br/ >1.Male or female (non-pregnant) subject between â?¥ 18 to 55 years of age. <br/ >2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment. <br/ >Inclusion Criteria ONLY for Phase III: <br/ >1.Male or female subject between â?¥ 18 to 80 years of age. <br/ >Inclusion Criteria for Phase II and Phase III: <br/ >1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study. <br/ >2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment. <br/ >4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ >6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ >7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ >8.Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Subject agrees to refrain from blood donation during the course of the study. <br/ >10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ > <br/ > <br/ >