CTRI/2011/06/001787已完成3 期
A phase III, multicentric, randomized single-blind study to evaluate the safety and the immunogenicity of El-Shaddai Biologicals? varicella zoster vaccine in comparison to GlaxoSmithKline Biologicals? Varilrix® in healthy subjects aged 1 to 12 years. - Nil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
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.Indian males and females aged 1 to 12 years at the time of vaccination.
- •2.Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •3.Subject or subject?s parent/guardian must understand and sign a written informed consent.
- •4.Subjects who are willing to comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) and are available for all clinic visits scheduled in the study.
排除标准
- •1.Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
- •2.History of hypersensitivity, convulsion, epilepsy, psychosis, thrombocytopenia, coagulation disorder, and contraindications to subcutaneous injection.
- •3.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •4.Individuals who have had chickenpox vaccine prior to Day 0 or documented confirmed or suspected chickenpox disease.
- •5.Hypersensitivity or intolerance to erythromycin and kanamycin.
- •6.Receipt of another investigational product within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study.
- •7.Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination
- •8.Known or suspected impairment/alteration of immune function, for example resulting from:
- •a.receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 6 months prior to Visit 1
- •b.cancer chemotherapy
- •c.receipt of immunostimulants within 6 months prior to Visit 1
- •d.receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study
- •e.known HIV infection or HIV-related disease.
- •9.Individuals with axillary temperature ≥ 38.0°C within 3 days/on the day of intended study vaccination and/or moderate to severe acute illness/infection on the day of vaccination.
- •10.History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions).
- •11.Individuals with any serious chronic or progressive disease and congenital malformation or maldevelopment according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease, Down?s syndrome).
- •12.Bleeding diathesis.
- •13.Suffering from serious dermatoses (such as allergy, herpes, suppuration and fungal infection.
- •14.Planned surgery during the study period that in the Investigator?s opinion would interfere with the study visits schedule.
- •15.Relatives of research staff (The families of the site staff who are not involved in this trial are allowed their participation to this trial).
研究者
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