CTRI/2019/02/017774已完成3 期
A Phase 3, Multicenter, Open-Label, Randomized Clinical Trial to evaluate Safety and Immunogenicity of ROTAVAC® -20�C and Rotavac 5CM administered at Birth (Neonatal Schedule) and Additional Dose versus Infant Schedule against Rotavirus Gastroenteritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 408
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
入选标准
- •1 Healthy male or female full term (>=36 weeks gestation) babies weighing at least 2500g
- •at birth. Healthiness established by medical history and clinical examination
- •2 Resident of a state in India where ROTAVAC® is not introduced as a part of UIP
- •3 Subjects whose either of parent or guardian is able to understand planned study
- •procedures and demonstrate comprehension of the protocol procedures prior to
- •vaccination.
- •4 Subjects whose parent or guardian, in the opinion of the investigator, can and will
- •comply with the requirements of the protocol (eg completion of the diary cards, return
- •for follow-up visits).
- •5 Written informed consent obtained from the subjects parent or guardian prior to
- •performance of any study specific procedure.
- •6 Generally healthy subjects without acute or chronic, clinically significant pulmonary,
- •cardiovascular, hepatic or renal functional abnormality, as determined by physical
- •examination.
- •7 Infants receiving vaccines as per Universal Immunization Program of India
- •8 Subjects with no history of rotavirus vaccination prior to study enrolment and whose
- •parent or guardian is willing to forego any outside rotavirus vaccination during the
- •entire study period.
- •9 Subjects with a minor illness [such as low-grade fever between 36.5°C (97.7°F) and
- •37.5°C (99.5°F) and mild upper respiratory infection] may be enrolled at the discretion
- •of the investigator.
排除标准
- •1 Use of any investigational or non-registered product (drug or vaccine) other than the
- •study vaccines during the study period
- •2 Concurrently participating in another clinical study, at any time during the study
- •period, in which the subject has been or will be exposed to an investigational or a
- •non-investigational vaccine/product (pharmaceutical product or device).
- •3 Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab)
- •since birth or planned administration any time during the study period.
- •4 Any confirmed or suspected immunosuppressive or immunodeficient condition,
- •based on medical history and physical examination (e.g. Severe Combined
- •Immunodeficiency Disease).
- •5 Neonates born to mother Infected with Human Immunodeficiency Virus (HIV)
- •regardless of clinical stage of immunodeficiency.
- •6 History of or current autoimmune disease.
- •7 Administration of immunoglobulins and/or any blood products since birth or planned
- •administration during the study period
- •8 History of uncorrected congenital malformation of the gastrointestinal tract.
- •9 History of intussusception.
- •10 History of any reaction or hypersensitivity likely to be exacerbated by any component
- •of the vaccines.
- •11 Hypersensitivity to latex.
- •12 Presence of significant malnutrition or any systemic disorder (cardiovascular,
- •pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine,
- •immunological, dermatological, neurological, cancer or autoimmune disease) as
- •determined by medical history and/or physical examination which would compromise
- •the childâ??s health or is likely to result in non-conformance to the protocol.
- •13 Acute disease and/or fever at the time of enrolment.
- •a Fever is defined as temperature >=38.0°C/100.4°F. The preferred location for
- •measuring temperature in this study will be underarm (axillary) temperature
- •first. If that reading is >99ï?°F, take rectal temperature for a more precise and
- •accurate result
- •b Subjects with acute diarrhea and/or vomiting within last 24 hours
- •14 Have signs or symptoms that could confound or confuse assessment of study
- •vaccine reactogenicity
- •15 Any medical condition in the parents/ infant which, in the judgment of the
- •Investigator, would interfere with or serves as a contraindication to protocol
研究者
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