A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,020
- 主要终点
- Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
研究概览
简要总结
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Parent or legal guardian agrees to have infant participate by giving written informed consent
排除标准
- •History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- •History of intussusception
- •Known or suspected impairment of immunological function, including Severe
- •Combined Immunodeficiency (SCID)
- •Prior administration of any rotavirus vaccine
- •Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
- •Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
- •Residing in a household with an immunocompromised person
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins
- •Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
- •Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
研究组 & 干预措施
RotaTeq™ Experimental Formulation
Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)
干预措施: RotaTeq™ experimental formulation (Biological)
RotaTeq™ Existing Formulation
Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
干预措施: RotaTeq™ existing formulation (Biological)
结局指标
主要结局
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
时间窗: 42 days after vaccination 3 (up to 185 days)
次要结局
- Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability(Up to 7 days after any vaccination (up to 147 days))
- Number of Participants With Tier-1 Adverse Events: Intussusception(Up to Day 185)
- Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A(42 days after vaccination 3 (up to 185 days))
- Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8](Baseline and 42 days after vaccination 3 (up to 185 days))