Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Change seroconversion after one dose of trivalent vaccine OPV
研究概览
简要总结
Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.
Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.
详细描述
This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns babies
- •Weight ≥ 2.5 kg
- •Have not received any doses of Polio Vaccine
- •Whose parents or guardians reside in the work area
- •Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).
排除标准
- •Born of a high-risk pregnancy.
- •Weight ≤ 2.5 kg
- •Presence of fever, diarrhea, known immunosuppression, respiratory infections.
- •Treatment with immunosuppressants.
- •Having neurological diseases.
- •Require or received surgery in oropharynx.
结局指标
主要结局
Change seroconversion after one dose of trivalent vaccine OPV
时间窗: after the first dose is taken blood samples (baseline, 30 and 60 days)
次要结局
- Evaluate the adverse events in newborns babies(inmediately after treatment and during 60 days)