EUCTR2006-005191-41-AT进行中（未招募）不适用
Single blind, randomized, active controlled Phase 1/2 study to compare the safety and immunogenicity of a Split Virus, Vero cell-derived, seasonal influenza vaccine (VCIV) with a licensed egg-derived, Split Virus, seasonal influenza vaccine (EIV) - Phase 1/2 Split Virus Influenza Vaccine Trial
Baxter Healthcare Corporation, Baxter BioScience0 个研究点目标入组 1,000 人开始时间: 2006年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects will be eligible for participation in this study if they:
- •- Are 18 to 49 years of age, inclusive, on the day of screening (Stratum A)
- •- Are 50 years of age or older on the day of screening (Stratum B)
- •- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- •- Are clinically healthy (in a physical condition such that the physician would have no reservations administering influenza vaccine outside the scope of a clinical study)
- •- Are physically and mentally capable of participating in the study
- •- Agree to keep a daily record of symptoms
- •- If female and capable of bearing children – have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination.
- •- Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, AND
- •- An additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will be excluded from this study if they:
- •- Have previously been vaccinated against influenza with vaccine formulated for the 2006/2007 influenza season
- •- Have an oral temperature of ?37.5? C at the time of vaccination on Day 0* (See Note Below)*
- •- Have Type I diabetes
- •- Have a Body Mass Index > 35
- •- Have hypertension at screening (with or without medication) that is graded as greater than Stage 1 defined as a systolic pressure > 159 or diastolic pressure > 99 while seated and at rest (Measurement may be repeated twice before subject is absolutely excluded)
- •- Have clinically significant abnormal clinical laboratory values at screening
- •- Have clinically significant electrocardiographic abnormalities at screening
- •- Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
- •- Have a history of cardiovascular disease that required hospitalization
- •- Have a history of immunodeficiency or autoimmune diseases
- •- Have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months;
- •- Suffer from active neoplastic disease or have a history of hematologic malignancy
- •- Suffer from a disease or are undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) cortico-steroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- •- Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis)
- •- Have received any vaccination within 2 weeks prior to vaccination in this study
- •- Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study
- •- Have donated blood or plasma within 30 days prior to vaccination in this study
- •- Have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications)
- •- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- •- Have a positive urine drug screen, (Unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
- •- Were administered an investigational drug within six weeks prior to study entry
- •- Are concurrently participating in a clinical study that includes the administration of an investigational product
- •- Are a member of the team conducting this study
- •- re in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator
- •- If female, are pregnant or lactating.
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