Study on the Immunogenicity of Oral Polio Vaccine (OPV) and Oral Cholera Vaccine (OCV) When Co-administered
试验速览
- 阶段
- 3 期
- 入组人数
- 579
- 试验地点
- 2
- 主要终点
- Anti-poliovirus antibodies
研究概览
简要总结
Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available whole-cell killed Oral Cholera Vaccine (OCVs) with other oral vaccines, specifically, oral polio vaccines (OPV) is lacking. Although the risk of immunological interference due to co-administration of live vaccines with non-live vaccines is considered small if at all, a theoretical concern of interference has been raised. Given the substantial geographic correlation between polio- and cholera-affected and at-risk areas, which include some of the world's most impoverished and hard-to-reach populations, a strategy of co-administration of OCV with OPV to children targeted to receive OPVs has the potential to optimize the use of limited resources and improve coverage for both vaccines. The manufacturer recommendation for a two-week interval between administration of OPV and OCV precludes an integrated campaign or routine use in which OCV could be co-administered with OPV.
详细描述
Objectives of the study:
Primary :
- To compare seroconversion for OPV types P1 and P3 when administered alone versus when administered with OCV on day 28 and 56 after vaccination.
- To compare vibriocidal antibody response (based on a ≥ 4-fold rise) to OCV when administered alone versus when co-administered with OPV on day 28 and day 56 after vaccination.
Secondary: 3. To determine safety of co-administration of OPV with OCV compared to OPV or OCV alone.
Hypothesis:
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
- Single (Outcomes Assessor)
盲法说明
Laboratory staff will remain blinded throughout the study
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy children aged 1 to 3 years of age. Family able to understand and comply with planned study procedures and consents to be in the study.
- •Have received either no dose or only one dose of OPV ( 0 - 1 dose) and has not received any dose of IPV or OCV at any time before enrollment based upon immunization card record or history from parents.
排除标准
- •Parents and children who are unable / unwilling to participate in the full length of the study for any reason.
- •Child / family planning on moving away from the study area during the study period
- •A diagnosis, suspicion of, or clinical condition consistent with an immunodeficiency disorder (either in the child or in a member of the immediate family) or is on long-term (>3 months) of immunosuppressive therapy.
- •A suspicion or known history of bleeding disorder that would contraindicate venipuncture.
- •Acute diarrhea, infection or illness at the time of the first visit that would require the child's admission to a hospital or would contraindicate provision of OPV per country guidelines.
- •History of severe allergic reaction to component of study vaccine
- •Acute vomiting or diarrhea within 24 hours before the first visit.
- •Severely malnourished children (Weight-for-age with z-score < - 3 below the median of the WHO child growth standards.)
- •Previously received 3 doses of OPV or single dose of IPV or OCV at any time before enrollment based upon immunization card record.
结局指标
主要结局
Anti-poliovirus antibodies
时间窗: One year
Anti-poliovirus antibodies P1 and P3 microneutralization titer when OPV and OCV are administered separately, and when given together.
Vibriocidal antibody response
时间窗: One year
Vibriocidal antibody response to V. cholerae O1, serotype Ogawa and Inaba when OPV and OCV are administered separately, and when given together.
次要结局
- Safety: number of adverse events and serious adverse events(One year)