Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 482
- 试验地点
- 1
- 主要终点
- Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
研究概览
简要总结
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
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 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child 9 months of age eligible for measles-rubella vaccination
- •documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
- •healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
- •parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent
排除标准
- •hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
- •history of intussusception, intestinal malformations, or abdominal surgery
- •known history of measles and/or rubella disease
- •history of previous receipt of measles and/or rubella vaccine
- •use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
- •current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
- •any participant who reports planning to leave the study area before the completion of the study
- •acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
- •acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.
研究组 & 干预措施
measles-rubella vaccine
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age
干预措施: measles-rubella vaccine (Biological)
measles-rubella and rotavirus vaccines
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age
干预措施: measles-rubella vaccine (Biological)
measles-rubella and rotavirus vaccines
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age
干预措施: Rotarix vaccine (Biological)
结局指标
主要结局
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
时间窗: 8 weeks post vaccination
Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
时间窗: 8 weeks post vaccination
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
次要结局
- Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)(8 weeks post vaccination)
- Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)(8 weeks post vaccination)
- Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)(Visit 1 (pre-vaccination) and 8 weeks post vaccination)
- Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)(Visit 1 (pre-vaccination) and 8 weeks post vaccination)
- Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)(Visit 1 (pre-vaccination) and 8 weeks post vaccination)
- Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)(Visit 1 (pre-vaccination) and 8 weeks post vaccination)
- Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)(8 weeks post vaccination)
- Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)(8 weeks post vaccination)
- Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine(30 minutes post-vaccination)
- Number/Percentage of Subjects Experiencing Solicited Adverse Events(14 days post-vaccination)
- Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events(14 days post-vaccination)
- Number/Percentage of Subjects Experiencing Serious Adverse Events(2 months after vaccination)