Created at Source Raw Value Validated value
May 5, 2022, 11:30 p.m. oms

Inclusion Criteria for Phase II: <br/ >1.Male and female subjectsâ?? 5- <18 years. <br/ >2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator. <br/ >3.Age group 12 - <18 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study. <br/ >4.Age group: 5 - 11 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study <br/ >5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 <br/ >6.Subject/ subjectâ??s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. <br/ > <br/ >Inclusion Criteria for Phase III: <br/ >1.Male and female subjectsâ?? 5 - <18 years. <br/ >2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. <br/ >3.Age group 12 - <18 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent and subjectâ??s should be capable and willing to give voluntary assent form prior to inclusion in the study. <br/ >4.Age group: 5 - 11 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study. <br/ >5.Subjectâ??s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. <br/ >

Inclusion Criteria for Phase II: <br/ >1.Male and female subjectsâ?? 5- <18 years. <br/ >2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator. <br/ >3.Age group 12 - <18 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study. <br/ >4.Age group: 5 - 11 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study <br/ >5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 <br/ >6.Subject/ subjectâ??s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. <br/ > <br/ >Inclusion Criteria for Phase III: <br/ >1.Male and female subjectsâ?? 5 - <18 years. <br/ >2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. <br/ >3.Age group 12 - <18 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent and subjectâ??s should be capable and willing to give voluntary assent form prior to inclusion in the study. <br/ >4.Age group: 5 - 11 years: <br/ >Subjectâ??s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study. <br/ >5.Subjectâ??s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. <br/ >