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

1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <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.Participants of either gender between �18 to �55 years of age at phase-I and �18 to �65 years of age at phase-II at the time of 1st vaccination. <br/ >4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of �60 to �100 bpm, blood pressure systolic of �90 mm Hg and <140 mm Hg, diastolic � 60 mm Hg and <90 mm Hg, body temperature <100.4ºF prior to enrolment]. <br/ >7.Female participants of child bearing potential negative to urine pregnancy test 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, <br/ >8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Agrees to refrain from blood donation during the course of the study. <br/ >10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >

1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <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.Participants of either gender between �18 to �55 years of age at phase-I and �18 to �65 years of age at phase-II at the time of 1st vaccination. <br/ >4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of �60 to �100 bpm, blood pressure systolic of �90 mm Hg and <140 mm Hg, diastolic � 60 mm Hg and <90 mm Hg, body temperature <100.4ºF prior to enrolment]. <br/ >7.Female participants of child bearing potential negative to urine pregnancy test 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, <br/ >8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Agrees to refrain from blood donation during the course of the study. <br/ >10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >

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

Dec. 5, 2020, 12:45 a.m. oms

1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <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.Participants of either gender between �18 to �55 years of age at phase-I and �18 to �65 years of age at phase-II at the time of 1st vaccination. <br/ >4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of �60 to �100 bpm, blood pressure systolic of �90 mm Hg and <140 mm Hg, diastolic � 60 mm Hg and <90 mm Hg, body temperature <100.4ºF prior to enrolment]. <br/ >7.Female participants of child bearing potential negative to urine pregnancy test 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, <br/ >8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Agrees to refrain from blood donation during the course of the study. <br/ >10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >

1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <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.Participants of either gender between �18 to �55 years of age at phase-I and �18 to �65 years of age at phase-II at the time of 1st vaccination. <br/ >4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ >6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of �60 to �100 bpm, blood pressure systolic of �90 mm Hg and <140 mm Hg, diastolic � 60 mm Hg and <90 mm Hg, body temperature <100.4ºF prior to enrolment]. <br/ >7.Female participants of child bearing potential negative to urine pregnancy test 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, <br/ >8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ >9.Agrees to refrain from blood donation during the course of the study. <br/ >10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >