Co-administration Study of OCV, TCV and MR
Typhoid, Cholera, Measles
About this trial
This is an interventional prevention trial for Typhoid focused on measuring Co-administration, Immunogenicity, Safety, Typhoid fever, Cholera, Measles and Rubella, Conjugate vaccine
Eligibility Criteria
Inclusion Criteria: Provide informed written consent from participants parent/legal guardian Participants aged 12 months to 59 months Family does not have any plan to move from the study area during study period No history of receipt of MR (Measles and Rubella) or TCV or OCV Exclusion Criteria: Child live outside of the study area Participant with confirmed or suspected immunosuppressive or immunodeficiency disorder; or participant on any immunosuppressive or immunostimulant therapy Known case of thrombocytopenia or any coagulation disorder, or participant on anticoagulation therapy History of hypersensitivity reaction to any component of the study vaccines Participant with febrile illness (temperature >37.9oC) at the time of enrollment Participant with acute diarrhea and/or vomiting at the time of enrollment Participant with acute infection or illness at the time of enrollment Participant is severely malnourished
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm A: Oral Cholera Vaccine (OCV) only
Arm B: Typhoid Conjugate Vaccine (TCV) only
Arm C: Measles and Rubella (MR) only
Arm D: Co-administration of Measles and Rubella (MR) and Typhoid Conjugate Vaccine (TCV)
Arm E: Co-administration of Measles and Rubella (MR) and Oral Cholera Vaccine (OCV)
Arm F: Co-administration of Typhoid Conjugate Vaccine (TCV) and Oral Cholera Vaccine (OCV)
Based on randomization (n= 413) Potential participants will be vaccinated with OCV on Day 0 and Day 28. Two doses of MR vaccine will be given on day 56 and day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28, Day 56, Day 84 and Day 264 . All details will be recorded in the eCRF.
Based on randomization (n= 314) Potential participants will be vaccinated with TCV on Day 0 and two doses of MR vaccine will be given on Day 56 and Day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28, Day 84 and Day 264 . All details will be recorded in the eCRF.
Based on randomization (n= 250) Potential participants will be vaccinated with MR on Day 0 and Day 180. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 and Day 208 . All details will be recorded in the eCRF.
Based on randomization (n= 314) Potential participants will be vaccinated with TCV on Day 0 and two doses of MR vaccine will be given on Day 0 and Day 180 . A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 and Day 208 . All details will be recorded in the eCRF.
Based on randomization (n= 413) Potential participants will be vaccinated with OCV on Day 0 and Day 28 . Two doses of MR vaccine will be given on Day 0 and Day 180 . A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 , Day 56 and Day 208 . All details will be recorded in the eCRF.
Based on randomization (n= 413) Potential participants will be vaccinated with TCV on Day 0 . Two doses of OCV vaccine will be given on Day 0 and Day 28. Also two doses of MR vaccine will be given on Day 56 and Day 236. A blood sample (2-3 ml) will be collected for immunological assay on Day 0, Day 28 , Day 56 , Day 84 and Day 264 . All details will be recorded in the eCRF.