Immunogenicity and Safety of Concurrent Administration of Live, Attenuated SA 14-14-2 Japanese Encephalitis Vaccine and Measles-Mumps-Rubella Vaccine in Infants 9-12 Months of Age in the Philippines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 628
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
研究概览
简要总结
This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.
详细描述
When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.
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
入排标准
- 年龄范围
- 9 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 9 months to < 10 months at the time of enrollment.
- •Residence in the study area.
- •At least one parent or guardian willing to provide written informed consent.
- •Generally healthy and free of obvious health problems as established by medical history, physical examination, and clinical judgment.
- •A parent or guardian is willing to attend all planned study visits and allow home visits and phone contacts, as required by the protocol.
排除标准
- •Previous receipt of any measles-mumps-rubella containing vaccine.
- •Previous receipt of any Japanese encephalitis vaccine.
- •History of measles, mumps, rubella, or Japanese encephalitis infection.
- •Administration of any other vaccine within 28 days prior to administration of a study vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI vaccines or oral polio vaccine during the 28 days after study vaccination.
- •History of allergic disease or known hypersensitivity to any component of the study vaccines and/or following administration of vaccines included in the local program of immunization.
- •Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines or planned administration during the study period.
- •Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the study period.
- •Chronic administration (defined as > 7 days) of immunosuppressing or other immune-modifying agents within 14 days before or after vaccination (including systemic corticosteroids equivalent to prednisone ≥ 0.5 mg/kg/day; topical and inhaled steroids are allowed).
- •Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency as reported by parent.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history or physical examination, which might interfere with the study objectives.
- •Severely malnourished infants as measured by World Health Organization weight-for-height tables (Z-score < -3).
- •Any condition or criterion that, in the opinion of the study physician, might compromise the well-being of the participant, compliance with study procedures, or interpretation of the outcomes of the study.
- •Acute illness at the time of enrollment defined as the presence of a moderate or severe illness with fever (axillary temperature ≥ 38.0°C) or without fever (severity determined at the discretion of the study physician). Acute illness is a temporary exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for reassessment may be scheduled 7 days or more after temporary exclusion illness is resolved. Eligibility for study participation must be reassessed again at the next visit.
结局指标
主要结局
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
时间窗: 56 days after MMR dose 1 vaccination (Day 56)
Measles immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for measles at 56 days post-vaccination. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT) (dilution converted to concentration using the 3rd International Standard Reference serum).
Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination
时间窗: 56 days after MMR dose 1 vaccination (Day 56)
Rubella immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for rubella at 56 days post-vaccination. Seropositivity was defined as antirubella immunoglobulin G (IgG) concentration of ≥ 10 IU/mL (corresponding to an optical density ratio ≥ 1.10) using a commercial IgG enzyme-linked immunosorbent assay (ELISA).
次要结局
- Seroconversion Rate for Mumps 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity(30 minutes through 14 days following each vaccination)
- Seroconversion Rate for Measles 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination(28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2))
- Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination(30 minutes through 14 days following each vaccination)
- Seroconversion Rate for Rubella 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination(28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2))
- Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination(30 minutes following each study vaccination)
- Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination(28 days following each vaccination)
- Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination(56 days after MMR dose 1 vaccination (Day 56))
- Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity(30 minutes through 14 days following each vaccination)
- Number of Participants With Serious Adverse Events Throughout the Study(Up to 112 days)