Co-administration Study of OCV, TCV and MR

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Mar 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of giving three vaccines—against cholera, measles, and rubella—together to young children aged 12 to 59 months in Dhaka, Bangladesh. The goal is to see if these vaccines can be safely administered at the same time without affecting their effectiveness. The study will involve about 2,117 children who have not yet received any of these vaccines. Parents or guardians will be asked for permission to enroll their children, and the children will be randomly placed into different groups to receive the vaccines.

To be eligible for the trial, children must be between 1 and 4 years old and must not have received the cholera, measles, or rubella vaccines before. They should also be living in the study area and not planning to move during the study. Participants will have a small amount of blood drawn for testing at various times throughout the trial. It's important to note that children with specific health conditions or illnesses won’t be included in the study, ensuring the safety of all participants. This study could help improve vaccination strategies for children in the future, making it easier to protect them from these serious diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provide informed written consent from participants parent/legal guardian
• • 2. Participants aged 12 months to 59 months
• • 3. Family does not have any plan to move from the study area during study period
• • 4. No history of receipt of MR (Measles and Rubella) or TCV or OCV
• Exclusion Criteria:
• • 1. Child live outside of the study area
• • 2. Participant with confirmed or suspected immunosuppressive or immunodeficiency disorder; or participant on any immunosuppressive or immunostimulant therapy
• • 3. Known case of thrombocytopenia or any coagulation disorder, or participant on anticoagulation therapy
• • 4. History of hypersensitivity reaction to any component of the study vaccines
• • 5. Participant with febrile illness (temperature \>37.9oC) at the time of enrollment
• • 6. Participant with acute diarrhea and/or vomiting at the time of enrollment
• • 7. Participant with acute infection or illness at the time of enrollment
• • 8. Participant is severely malnourished