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临床试验/CTRI/2019/01/016891
CTRI/2019/01/016891已完成1 期

A prospective, single arm, Phase I open label study to assess the reactogenicity and safety of a combined liquid DTwP-rHepB-Hib-IPV vaccine when administered to healthy children 16-24 months of age as a single dose. - None

Biological ELimited0 个研究点目标入组 24 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
已完成
发起方
入组人数
24
研究概览入排标准研究者记录与标识符相似试验

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. Subjectsâ?? 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 D, T, (wP or aP), HepB, Hib and polio 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.
  • •Please refer to the GLOSSARY OF TERMS for the definition of child in care.
  • •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 ï?³ 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, hepatitis B, poliomyelitis and/or H. influenzae type b diseases.
  • •8.Known exposure to diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis 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.
  • •oFever is defined as the endogenous elevation of at least one measured body temperature of >= 38â?¦C (>= 100.4â?¦F).8
  • •oSubjects 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, poliomyelitis, hepatitis B 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 neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • •21.Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
  • •- encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,

研究者

发起方
Biological ELimited

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