Non-interference Study of MR and Yellow Fever Vaccines Among Bangladeshi Infants Aged 9-12 Months

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the measles, rubella, and yellow fever vaccines work when given together to healthy infants aged 9 to 12 months. The researchers will enroll about 1,530 infants from specific areas in Dhaka, Bangladesh, who have not received these vaccines before. The goal is to understand if giving these vaccines at the same time is safe and effective, which could help improve vaccination programs in the future.

To be eligible for this study, infants must be healthy and aged between 9 to 12 months, and their parents or guardians must provide written consent for participation. Infants who have had certain infections or other medical conditions may not be able to join. Participants will receive vaccinations and have follow-up visits where blood samples will be collected to monitor their immune response and any side effects. Parents will also keep track of any health events that occur after vaccination. This study is important because it could help guide how these vaccines are given together, ensuring better health outcomes for children in the region.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * The participant must satisfy all the following criteria to be eligible for enrolment:
• • Healthy infant participants of either gender aged\* 9 to 12 months at the time of enrollment
• • Participants should be in good health as determined by the medical history and physical examination based on the clinical judgment of the investigator
• • No previous history of vaccination against measles, rubella, or Yellow fever
• • Written informed consent from the participant's parent/guardian
• • Participant's parent/guardian literate enough to fill the diary card \*Age calculated as per completed month
• Exclusion Criteria:
• • Participants positive for serological markers against Dengue and/or Japanese Encephalitis infections
• • History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins
• • History of hypersensitivity reaction to neomycin
• • History of laboratory-confirmed or suspected measles, rubella, or Yellow fever in the past
• • Participant exposed# to measles, rubella, or Yellow fever virus within the past 30 days
• • Fever of any origin or infectious disorder of 3 days or more within the past month
• • Febrile illness (axillary temperature ≥37.5°C) at the time of enrollment
• • History of any vaccination within the past month
• • Clinically significant systemic disorders such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, immunological, or metabolic disorder
• • Confirmed or suspected immunosuppressive or immunodeficiency disorder; or participants on any immunosuppressive or immunostimulant therapy
• • Known case of thrombocytopenia or any coagulation disorder, or participants on anticoagulation therapy
• • Participants administered blood, blood-containing products, or immunoglobulins within the last 3 months or planned administration during the study
• • Participant participated in another clinical study in the past 3 months
• • Any other reason for which the investigator feels that the participant should not participate #Close contact (family member or neighbour) with laboratory-confirmed or clinical diagnosis of measles/rubella/Yellow fever