Measles Clinical Trial
Official title:
A Co-administration Study of Oral Cholera Vaccine (OCV), Typhoid Conjugate Vaccine (TCV), Measles and Rubella (MR) Vaccines in Bangladesh
An open-label, randomized controlled, non-inferiority study of co-administration of OCV, TCV and MR vaccines among children 12 to 59 months of age in Dhaka, Bangladesh will be conducted. Children who did not receive any of the aforementioned vaccines will be included in the study. This study will be conducted among 2117 children of 12-59 months of age residing in Mirpur area (wards 4, and 6-16) of Dhaka north and Kamrangirchar, Hazaribag and Rayerbazar areas (wards 14, 22, 56, 57, and 58) of Dhaka south to enroll the required number of participants. Only children who have not previously received the vaccines will be enrolled. The findings of this study are likely to have a significant impact on vaccine co-administration strategies for campaign and routine immunization programs. The participants will be randomly assigned to one of the six arms. The numbers are defined for each arm based on the sample size calculation. A list of children who did not receive MR, OCV and TCV will be prepared before enrollment by trained study staff (TSS). The TSSs will visit households in the defined study area and ask if the parents/guardians of children aged 12-59 months are willing to participate in the study. If they show willingness to participate, the TSSs will check their vaccination cards (if available) and prepare the list of potentially eligible children who have not received OCV, TCV and MR based on their vaccination card status and verbal statement (if vaccination card is not available). The investigators will enroll the participants after obtaining informed written consent and collect around 2-3 ml blood from each participant at different time points.
Status | Not yet recruiting |
Enrollment | 2117 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 59 Months |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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International Centre for Diarrhoeal Disease Research, Bangladesh | Centers for Disease Control and Prevention |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vibriocidal antibody response for OCV | Vibriocidal antibody response for OCV when administered individually versus when co-administered with TCV on days 28 and 56
Vibriocidal antibody response for OCV when administered individually versus when co-administered with MR on days 28 and 56 |
Two months | |
Primary | Seroconversion for TCV | Seroconversion (=4 fold rise of anti-Vi-IgG antibody titres compared to pre-vaccination) for TCV when administered individually versus when co-administered with OCV on day 28
Seroconversion (=4 fold rise of anti-Vi-IgG antibody titres compared to pre-vaccination) for TCV when administered individually versus when co-administered with MR on day 28 |
One Year | |
Primary | Seroconversion for MR vaccine | Seroconversion (=4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when co-administered with OCV on days 28 and 208
Seroconversion (=4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when co-administered with TCV on days 28 and 208 Seroconversion (=4 fold rise of measles IgG antibody titres compared to pre-vaccination) for MR when administered individually versus when administered after OCV on days 84 and 264 |
One year | |
Primary | Safety: number of adverse events and serious adverse events | Number of adverse events and serious adverse events when OCV, TCV and MR vaccines are co-administered versus given alone. | One year |
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