Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 793
- 主要终点
- Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
研究概览
简要总结
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
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
- Double (Participant, Investigator)
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
- •Healthy infants
排除标准
- •History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- •Known or suspected problems with the immune system
- •Fever at time of immunization
- •Prior administration of a rotavirus vaccine
- •History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
研究组 & 干预措施
RotaTeq™ Lot 1
~8.81 X 10^7 IU/Dose of RotaTeq™
干预措施: rotavirus vaccine, live, oral, pentavalent (Biological)
RotaTeq™ Lot 2
~8.01 X 10^7 IU/Dose of RotaTeq™
干预措施: rotavirus vaccine, live, oral, pentavalent (Biological)
RotaTeq™ Lot 3
~6.91 X 10^7 IU/Dose of RotaTeq™
干预措施: rotavirus vaccine, live, oral, pentavalent (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
时间窗: 42 days following the 3rd vaccination
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
次要结局
未报告次要终点