CTRI/2014/06/004707已完成3 期
A Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Immunogenicity and Safety of H1N1-09 Influenza Virus-Like Particle (VLP) Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
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
- •Healthy volunteers of either sex between 18-64 years of age, inclusive
- •Informed consent must be obtained from the volunteer prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period
- •Receipt of any other licensed influenza vaccines or investigational influenza vaccine within 6 months prior to enrollment in this study or expected receipt of any vaccination before the final immune response blood collection
- •History of hypersensitivity to any component of inactivated influenza vaccines
- •Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the administration of the study vaccine (inhaled & topical steroids are allowed)
- •Use of systemic glucocorticoids within one month prior to randomization
- •Any clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests
- •Screening serum transaminase or alkaline phosphatase more than 3 times of ULN, creatinine and total bilirubin 1.5 times of ULN, Hgb 10 gm/dl, or BMI 28
- •Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- •Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
- •Administration of immunoglobulin and/or any blood products within the three months preceding the administration of the study vaccine or during the study
- •Acute illness of moderate or severe intensity at the time of enrollment, including any illness associated with fever ³100.5 0F
- •Any congenital abnormalities, including hemglobinopathies, which could increase the risk of influenza complications
- •History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to: multiple sclerosis, lupus, Guillain-Barre syndrome.
- •Women who are found to have a positive urinary pregnancy test; pregnant or lactating history or physical examination, or planning to become pregnant or to discontinue contraceptive precautions within 60 days of enrollment in this study
- •Volunteers found positive in drugs of abuse test
- •Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
- •Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results
研究者
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