A Co-administration Study of Oral Cholera Vaccine (OCV), Typhoid Conjugate Vaccine (TCV), Measles and Rubella (MR) Vaccines in Bangladesh
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,117
- 主要终点
- Seroconversion for TCV
研究概览
简要总结
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.
详细描述
The investigators will use an open-label, randomized controlled study design, to assess potential interference of antibody responses for different combinations of vaccines such as MR+TCV, MR+OCV and OCV+TCV. The study will be conducted among children aged 12-59 months in areas of urban Dhaka Bangladesh. Children will eligible for inclusion if they had not previously received OCV, TCV and MR.
Hypothesis:
Seroconversion following co-administration of OCV, TCV and MR at different combinations is non-inferior to seroconversion following administration of the vaccines alone.
Study activities:
Screening and eligibility assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is a open-label, randomized controlled, non-inferiority study. Study investigators along with study staff involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be un-blinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis. The DSMB will be responsible for un-blinding the randomization number codes in the event of severe putative vaccine reactions. Otherwise, the codes will not be revealed until the end of the trial and until the computerized dataset has been frozen. If the intervention assignment is un-blinded, all study collaborators will be notified immediately. If deemed necessary, the DSMBs will recommend unblinding to the IRB and contact the study statistician responsible for providing information on the vaccine received by the individual in question.
入排标准
- 年龄范围
- 12 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Seroconversion for TCV
时间窗: One Year
* 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
Vibriocidal antibody response for OCV
时间窗: Two months
* 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
Safety: number of adverse events and serious adverse events
时间窗: One year
Number of adverse events and serious adverse events when OCV, TCV and MR vaccines are co-administered versus given alone.
Seroconversion for MR vaccine
时间窗: One year
* 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
次要结局
未报告次要终点