CTRI/2014/04/004543已完成1 期
A Randomized, Comparative, Open Labeled, Multicentric, Phase I Study To Evaluate And Compare The Safety, Tolerability And Immunogenicity Of Two Formulations (With And Without Preservative) Of 10-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Nucovac® Of Panacea Biotec Ltd. With Synflorix® Of Glaxosmithkline Ltd. In Healthy Infants - Nucovac Infant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
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.Infants 6-10 weeks of age, whose parents/LAR willing to give written informed consent prior to the study entry.
- •2.Infants with good health as determined by:
- •Medical history
- •Physical examination
- •Clinical judgment of the investigator
- •3.Subjects judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.History of previous vaccination against S. pneumonia
- •2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically)
- •3.Infants expected to receive any vaccine other than the EPI schedule.
- •4.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •5.Known HBsAg positivity in mother.
- •6.Infants less than 6 weeks or more than 10 weeks of age.
- •7.Infants weighing less than 3.3 Kg at the time of enrollment.
- •8.Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition.
- •9.Known history of administration of blood or blood-derived products
- •10.Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulin, immunosuppressant or other immune-modifying drugs in past or at any time during the study.
- •11.Febrile illness (temperature >=38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- •12.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
- •13.Infants who have participated in another trial or received an investigational agent within 30 days of enrolment.
- •14. Infants with any clinically significant disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the infantâ??s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •15.History or presence of significant asthma, urticaria or other allergic reactions.
- •16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
- •17.Planned participation in another clinical trial during the trial period.
- •18.Subjectâ??s Parents/LAR planning to leave the area of study before completion of the study
研究者
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