NCT00757926撤回1 期
Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants 6-8 weeks of age of either sex;
- •Born after a gestational period of 36-42 weeks with birth weight >2 kg;
- •Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
- •Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
排除标准
- •History of congenital abdominal disorders, intussusception, or abdominal surgery;
- •Known or suspected impairment of immunological function;
- •Known hypersensitivity to any component of the rotavirus vaccine;
- •Prior receipt of any rotavirus vaccine;
- •Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
- •History of known rotavirus disease, chronic diarrhea, or failure to thrive;
- •Baseline level of ALT or AST >2.5 times the upper limit of normal;
- •Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
- •Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
- •Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
- •Infants testing positive for HBV, HCV, or HIV infection;
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- •Any infants who can not be adequately followed for safety by telephone and/or a home visit;
- •Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
结局指标
主要结局
Safety and tolerability
时间窗: Upto one month after each of the three doses of vaccine/ placebo
次要结局
- Immunogenicity(At one month after each of the three doses of vaccine/ placebo)
- Viral Shedding(After each of the three doses of the vaccine/placebo)
研究者
研究点 (2)
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