Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 735
- 主要终点
- GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
研究概览
简要总结
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants in good health
排除标准
- •Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
- •Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
- •Any condition resulting in depressed immunity
- •Any allergy to any vaccine component as stated in the package circulars
- •Allergies to polymyxin B, neomycin or any other antibiotics
- •Receipt of intramuscular, oral, or intravenous corticosteroid treatment
- •History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
- •History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
- •Prior receipt of a blood transfusion or blood products, including immunoglobulin
- •Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
- •Infants residing in a household with an immunocompromised person
结局指标
主要结局
GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)
时间窗: Approximately 42 days Postdose 3
GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered
时间窗: Approximately 42 days Postdose 3
Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3
时间窗: Approximately 42 days Postdose 3
GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
次要结局
未报告次要终点