EUCTR2022-003923-17-Outside-EU/EEA进行中（未招募）1 期
Safety and Immunogenicity Study of Full Schedule (3-Dose of Shan6™) or Shan6™-Shan5®-Shan6™ Versus the Licensed Vaccine Shan5® With bOPV (bivalent oral polio vaccine) and IPV (inactivated poliomyelitis virus) When Administered Per National Immunization Schedule in Healthy Kenyan Infants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 690
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- 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 4 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 >=0.5mg/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.
研究者
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