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

Adult Cohort: <br/ >1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ >4. Healthy, as determined by medical history and physical examination <br/ >5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit <br/ >6. Female participants of childbearing potential must have a negative <br/ >urine pregnancy test within 24 hours prior to study vaccine <br/ > <br/ >Pediatric Cohort: <br/ >1. Children aged â?¥ 2 to 17 years of either sex <br/ >2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study <br/ >3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator. <br/ >4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children <br/ >5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures. <br/ >6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration

Adult Cohort: <br/ >1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ >4. Healthy, as determined by medical history and physical examination <br/ >5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit <br/ >6. Female participants of childbearing potential must have a negative <br/ >urine pregnancy test within 24 hours prior to study vaccine <br/ > <br/ >Pediatric Cohort: <br/ >1. Children aged â?¥ 2 to 17 years of either sex <br/ >2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study <br/ >3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator. <br/ >4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children <br/ >5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures. <br/ >6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration

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

March 26, 2021, 2:21 p.m. oms

1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ >4. Healthy, as determined by medical history and physical examination <br/ >5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit <br/ >6. Female participants of childbearing potential must have a negative <br/ >urine pregnancy test within 24 hours prior to study vaccine

1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ >4. Healthy, as determined by medical history and physical examination <br/ >5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit <br/ >6. Female participants of childbearing potential must have a negative <br/ >urine pregnancy test within 24 hours prior to study vaccine