Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
研究概览
简要总结
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age 6 weeks through exactly 12 weeks
- •Healthy infants
排除标准
- •Clinical evidence of active gastrointestinal illness
- •Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
- •History of congenital abdominal disorders, intussusception, or abdominal surgery
- •History of known prior rotavirus disease
- •Known or suspected impairment of immunological function
- •Prior administration of any rotavirus vaccine
- •Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
研究组 & 干预措施
RotaTeq™ Vaccine (V260)
Evaluation of Safety, Tolerability and Immunogenicity of Vaccination with RotaTeq™ in Healthy Infants in India.
干预措施: Rotavirus Vaccine, Live, Oral, Pentavalent (Biological)
结局指标
主要结局
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
时间窗: Baseline and Approximately 6 Months
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
时间窗: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
时间窗: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
时间窗: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
时间窗: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
时间窗: Baseline and Approximately 6 Months
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
时间窗: Baseline and Approximately 6 Months
次要结局
未报告次要终点