CTRI/2020/01/022898已完成1 期
A single centre open label phase-I study to evaluate the safety and reactogenicity of single dose of BE’s liquid quadrivalent DTwP-Hib vaccine administered intramuscularly to 16-24 month old healthy Indian toddlers. - None
Biological ELimited0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- •2.Written or thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •3.A male or female child between and including 16 and 24 months of age at the time of vaccination.
- •4.Healthy subjects as established by medical history and clinical examination before entering into the study.
- •5.Documented routine childhood vaccinations, with at least complete primary vaccination for Diphtheria, Tetanus, Pertussis (wP or aP) and Hib as per national recommendation.
- •6.Born full-term (i.e. after a gestation period of at least 37 weeks).
- •7.Subjects that are negative for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C to the best of parent(s)/LAR(s) knowledge
排除标准
- •1.Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- •2.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
- •3.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •4.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ? 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •5.Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
- •6.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).
- •7.Evidence of previous or intercurrent diphtheria, tetanus, pertussis, and/or H. influenzae type b diseases.
- •8.Known exposure to diphtheria, tetanus, pertussis, and/or H. influenzae type b diseases.
- •9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •10.Family history of congenital or hereditary immunodeficiency.
- •11.History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •12.Major congenital defects.
- •13.History of any neurological disorders or seizures.
- •14.Acute disease and/or fever at the time of vaccination.
- •o Fever is defined as the endogenous elevation of at least one measured body temperature of = 38?C (= 100.4?F).8
- •o Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •15.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
- •16.Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
- •17.Administration of long-acting immune-modifying drugs at any time during the study period.
- •18.Previous booster vaccination against diphtheria, tetanus, pertussis, or H. influenzae diseases.
- •19.History of non-response to vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
- •20.Occurrence of transient thrombocytopenia or
研究者
相似试验
已完成
1 期
A clinical trial to evaluate the safety and reactogenicity of BEs Inactivated Japanese Encephalitis Vaccine.CTRI/2010/091/001086Biological E Limited20
已完成
1 期
A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 year old healthy male adults.CTRI/2019/04/018656Biological ELimited24
已完成
1 期
A phase-I clinical study to assess the safety of Biological Es Inactived Polio vaccine in 18-45 yearold healthy male adults.CTRI/2019/04/018474Biological ELimited24
撤回
1 期
A SINGLE CENTER OPEN-LABEL PILOT STUDY TO EVALUATE THE TOLERABILITY AND SAFETY OF A SYNTHETIC SOFT TISSUE IMPLANT MATERIAL IN THE SKIN OF NORMAL VOLUNTEERSTolerability and safety of a new synthetic soft tissue implant material for soft tissue augmentation in healthy volunteers.Surgery - Other surgeryACTRN12607000223437COSMETREND PTY LTD8
尚未招募
1 期
A Phase I/II open-label study at a single research center to evaluate the safety, tolerability, and effects of RGX-111 gene therapy given directly into the central nervous system in subjects with severe mucopolysaccharidosis type IMucopolysaccharidosis type IMucopolysaccharidosis IE76.0C16.320.565.202.715.640RBR-758cbnHospitais de Clínicas de Porto Alegre