A Co-administration Study of Oral Cholera Vaccine (OCV), Typhoid Conjugate Vaccine (TCV), Measles and Rubella (MR) Vaccines in Bangladesh

Status: Unknown
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 4
Healthy Volunteers: t
View:

• 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

Contact Information
Primary
Md Taufiqul Islam, MBBS, MPH
taufiqulislam@icddrb.org
+8801857597139
Time Frame
Start Date: 2023-10-14
Completion Date: 2025-05
Participants
Target number of participants: 2117
Treatments
Experimental: Arm A: Oral Cholera Vaccine (OCV) only
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.
Experimental: Arm B: Typhoid Conjugate Vaccine (TCV) only
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.
Experimental: Arm C: Measles and Rubella (MR) only
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.
Experimental: Arm D: Co-administration of Measles and Rubella (MR) and Typhoid Conjugate Vaccine (TCV)
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.
Experimental: Arm E: Co-administration of Measles and Rubella (MR) 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 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.
Experimental: 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 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.
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: International Centre for Diarrhoeal Disease Research, Bangladesh

This content was sourced from clinicaltrials.gov

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