PACTR202006580901172尚未招募3 期
Phase III, multi-center, randomized, active-controlled, open-label, three-arm, study in 690 infants who will receive a 3-dose primary series at 6, 10 and 14 weeks of age, of either 3-dose SHAN6™ or SHAN6™ – SHAN 5® + bOPV – SHAN6™ or SHAN 5® + bOPV – SHAN 5® + bOPV – SHAN 5® + bOPV + IPV, and a booster dose of either SHAN6™ or SHAN 5® + bOPV at 18 months of age
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 690
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Aged 42 to 56 days on the day of the first study visit.
- •- Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg OR medically stable prematurely born infants (born after a gestation period of 27-36 weeks).
- •- Infants who have received the birth dose of OPV and Bacille Calmette-Guérin vaccine (BCG) vaccine per Kenya NIS recommendations.
- •- Participants and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following the last trial vaccination except for routine vaccinations included in the Kenyan NIS (eg., BCG) which may be received less than 4 weeks before study vaccine.
- •- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection, poliomyelitis (except the OPV) or rotavirus infection apart from trial vaccines in the four weeks following trial vaccination.
- •- Receipt of immune globulins, blood or blood-derived products since birth.
- •- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent at >=0.5 mg/kg/day for more than 2 consecutive weeks since birth).
- •- Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg positive) or hepatitis C (HCV RNA positive).
- •- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- •- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, or rotavirus infection(s), confirmed either clinically, serologically, or microbiologically.
- •- History of seizures, encephalopathy, or any evolving or suspected neurological condition.
- •- History of intussusception.
- •- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
- •- Known thrombocytopenia, as reported by the parent/legally acceptable representative contraindicating IM vaccination.
- •- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- •- Chronic illness that, is at a stage where it might interfere with trial conduct or completion.
- •- Moderate or severe acute illness/infection on the day of vaccination or febrile illness (axillary temperature = 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided).
- •- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- •- Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
- •- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
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