CTRI/2012/10/003080已完成1 期
A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safetyand Immunogenicity of a H1N1-09 Influenza Virus-Like Particle (VLP) Vaccinein Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 180
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 adult with 18-65 years of age at the time of the vaccination.
- •During the first phase of recruitment (for DSMB review), no female subjects will be
- •Informed consent must be obtained from the subject 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.
- •Available by phone
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study
- •vaccine(s) 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.
- •The use of inhaled and nasal steroids will be permitted.
- •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 >=100.5 0F.
- •Any cardiopulmonary disease, including asthma, requiring ongoing medical therapy; known
- •or suspected abnormal hepatic or renal function, or 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.
- •Any condition that in the opinion of the investigator would interfere with evaluation of the
- •vaccine or interpretation of study results.
- •Females who are found positive in Urinary Pregnancy Test; Pregnant or lactating female,
- •and; Females planning to become pregnant or planning to discontinue contraceptive
- •precautions within 60 days of enrollment in this study.
- •Volunteers found positive in alcohol breath test and drugs of abuse test
研究者
相似试验
已完成
1 期
Influenza Vaccine studyCTRI/2012/10/003056Cadila Pharmaceuticals Limited180
尚未招募
Unknown
A clinical study to evaluatethe efficacy of JUVECOL K for period of 16 weeks in improving Knee Joint HealthCTRI/2024/07/070176aturetech co Ltd
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Paediatric (10 – 17 years old) Subjects with Type 2 DiabetesMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 DiabetesEUCTR2010-021057-39-BEovo Nordisk A/S21
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety/Tolerability, Pharmacokinetics & Pharmacodynamics of Liraglutide in Paediatric (10 – 17 years old) and Adult Subjects with Type 2 DiabetesMedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 DiabetesEUCTR2010-021057-39-SIovo Nordisk A/S60
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb-IV Non-Small Cell Lung Cancer (NSCLC) - NExUSon small cell lung cancerMedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2006-002688-26-ITBAYER990