PACTR201110000333955已完成未知
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy, Immunogenicity, and Safety of Two Single Doses of RRV TV in Neonates/Infants
International Medica Foundation0 个研究点目标入组 998 人开始时间: 2011年10月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 998
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 Day(s) 至 59 Day(s)（—）
- 性别
- All
入选标准
- •To be eligible for study entry, subjects had to satisfy all of the following criteria. If a subject failed to satisfy the eligibility criteria, he/she could be re-screened for the study.
- •1.The investigator considered that the subject¿s parent(s)/caregiver(s) could and would comply with the requirements of the protocol (e.g., return for follow up visits).
- •2.A male or female child, aged 0 to 29 days at the time of administration of the first dose of IP.
- •3.Informed consent was obtained from the parent(s)/caregiver(s) of the subject, who was/were of legal age as prescribed by the national regulations in Ghana. Because the study was conducted in a largely illiterate population, the consent was verbal and was obtained in accordance with center-specific SOPs for obtaining consent. The thumbprint of the subject¿s parent, obtained in the presence of an independent witness, served as confirmation of the understanding of the consent.
- •4.Healthy subjects, as established by medical history and clinical examination.
- •5.Birth weight >2000 g or, if birth weight was unknown, gestation period >37 weeks.
排除标准
- •Subjects were excluded from the study if one or more of the following statements were applicable:
- •1.Use, or planned use during the study period, of any investigational or non registered product (drug or vaccine) other than the study vaccine before administration of the first dose of IP.
- •2.Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non investigational product (pharmaceutical product or device).
- •3.Planned administration of a vaccine not recommended by the routine national vaccination program within 14 days before or after each dose of IP.
- •4.Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids were allowed.)
- •5.Any clinically significant history of chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract, intussusception, or other medical condition determined to be serious by the investigator.
- •6.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •7.History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- •8.Acute disease at the time of enrollment. (Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines were to be administered to subjects with a minor illness, such as mild upper respiratory infection with or without low grade febrile illness, i.e., axillary temperature <37.5°C, higher temperatures warranted deferral of vaccination).
- •9.GE (diarrhea [¿3 looser than normal or watery stools/24 h], with or without vomiting) within 7 days before administration of the first dose of IP (warrants deferral of the vaccination).
- •10.Previous confirmed occurrence of RV GE.
- •11.A family history of congenital or hereditary immunodeficiency.
- •12.Administration of immunoglobulins and/or blood products (excluding hepatitis B immune globulin [HBIG] since birth or planned administration during the study period.
- •13.History of any neurologic disorders or seizures.
- •14.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
研究者
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