CTRI/2013/05/003711进行中（未招募）1 期
A Randomized, Open Label, Comparative, Single Dose Phase I/II Study to Evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults - NUCOVAC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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 Subjects aged 18 to 65 years of age.
- •2.Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening.
- •3.Subject willing to give written informed consent and fulfill all study requirements
- •4.If female subjects and child bearing potential but practicing acceptable method of contraception or surgically sterile.
- •Acceptable methods of contraception are
- •Intra-uterine contraceptive device without hormone release system placed at least 4weeks prior to study drug administration
- •Effective method of barrier contraception like Condom or diaphragm with spermicidal gel/foam/film/cream/suppository
排除标准
- •1.History of previous vaccination against S. pneumoniae (in the previous 5 years).
- •2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
- •3.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •4.Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •5.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.
- •6.Known history of administration of blood or blood-derived products in the past 3 months.
- •7. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, lmmunosuppressants or other immune-modifying drugs in past or at any time during the study.
- •8.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.
- •9.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
- •10.Use of any investigational drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •11.Presence of chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment such as would endanger the volunteer or is likely to result in non conformance to the protocol.
- •12. Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures
- •13.History or presence of significant asthma, urticaria or other allergic reactions.
- •14.History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •15.Pregnant and/ or lactating mothers in case of female subjects.
- •16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
- •17.Participation in a drug research study within past 3 months.
- •18.Planned participation in another clinical trial during the trial period.
- •19.Subjects planning to leave the area of study before completion of the study.
研究者
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