Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between Rota Vaccine 5 and Rota Vaccine 1 Using Seven Combined Anti-rotavirus Prevention Programs: ROTA 1,ROTA 2,ROTA 3,ROTA 4,ROTA 5,ROTA 6,ROTA 7 in Infants at 2, 4 and 6 Months of Age in Mexico City.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,498
- 试验地点
- 2
- 主要终点
- General Symptoms - Temperature
研究概览
简要总结
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq) versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine), Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group 5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.
Secondary objectives
- To describe number and features of acute diarrheal disease (ADD) due to rotavirus displayed in the seven prevention schedules.
- To describe the adverse events temporarily associated with the seven prevention schedules.
Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages and the GMTs induced in subjects that received the routine vaccination schedules with two doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
详细描述
In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and 3erd visits for vaccine administration) phone calls every month and not schedule visits at the center when parents required and the last protocol visit was at one year of age This follow up to one year was to access security.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is a boy or a girl 2 months ± one week old at the time of the first dose of the vaccine.
- •The subject is considered to be healthy based on the clinical history and the physical examination.
- •The subject has not received any anti-rotavirus vaccine.
- •The parent/tutor fully understands the study's procedures and voluntarily accepts to participate and signs a written informed consent.
- •The parent/tutor can meet the study's requirements, such as attending the programmed visits and filling in the journal.
- •Written informed consent signed by the parent/tutor before any procedure.
排除标准
- •The subject has a background of serious allergic reaction to any of the vaccine's components.
- •The subject has a digestive tract malformation or acute/chronic disease.
- •The subject has some kind of immunodeficiency including HIV.
- •The subject suffers from a haemato-oncological disease.
- •The subject has been under treatment with an immunosuppressing medicine including prednisone for two or more weeks.
- •The subject has received gamma-globulin or any other blood-derived product or its administration is programmed during the study.
研究组 & 干预措施
ROTA 7
a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
干预措施: Rotarix (Biological)
ROTA 4
one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
干预措施: Rotarix (Biological)
ROTA 2
three doses of pentavalent vaccine RotaTeq
干预措施: RotaTeq (Biological)
ROTA 1
two doses of monovalent vaccine Rotarix followed by one dose of sterile water
干预措施: Rotarix (Biological)
ROTA 3
one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
干预措施: Rotarix (Biological)
ROTA 5
two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
干预措施: RotaTeq (Biological)
ROTA 6
one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
干预措施: RotaTeq (Biological)
ROTA 7
a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix
干预措施: RotaTeq (Biological)
ROTA 3
one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq
干预措施: RotaTeq (Biological)
ROTA 4
one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix
干预措施: RotaTeq (Biological)
ROTA 6
one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq
干预措施: Rotarix (Biological)
ROTA 5
two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix
干预措施: Rotarix (Biological)
结局指标
主要结局
General Symptoms - Temperature
时间窗: subsequent 5 days since the vaccination day
The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card . If the subject presents fever, the temperature will be recorded in a specific diary card section.
次要结局
- Evacuation(subsequent 30 days since the vaccination day)
研究者
Mercedes Macias Parra
MSc
National Institute of Pediatrics, Mexico