NCT01578070已完成1 期
A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Viscogel AB
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Incidence and type of adverse events, severe adverse events and SUSAR
研究概览
简要总结
The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have signed a written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
- •Subjects who are healthy and with no relevant medical history as determined by the investigator.
- •Subject that has not previously been known to be infected with or vaccinated against HIB, or exposed to patients diseased with HIB within a 4 months period prior to screening.
- •Male and non-lactating female subjects 22-50 years of age.
- •Two negative pregnancy tests if female (at screening and day 0)
- •Contraceptive use if female i.e. using a highly effective contraceptive method (implants, injectables, combined oral contraceptives, intra-uterine devices [including hormonal intra-uterine devices], sexual abstinence or vasectomised partner) for at least one month before dosing and willing to use it for at least one month after dosing.
- •Able to read and write Swedish.
排除标准
- •Known allergy to any component in Act-HIB, or who have had a serious reaction after previous administration of a vaccine.
- •Fever or acute disease including fever.
- •Receipt of immunoglobulins or blood products within three months prior to screening.
- •Donation of blood or suffered of blood loss of 450 ml within 3 months (4 months if female) prior to screening.
- •Donation of plasma within 14 days prior to screening.
- •Participation in other clinical study within 3 months prior to screening or previously dosed in this study.
- •Known or suspected immunodeficiency.
- •Vaccination received within a 2 months period prior to screening.
- •Any condition where regular use of inhaled, topical or oral corticosteroid is used.
- •Any condition where use of immunosuppressant is needed, e.g rheumatoid arthitis, cancer, transplantation, or treatment with immunomodulators, e.g. anti-TNF alpha, methotrexte, thioguanine, cyclophosphamide, cyclosporine, tacrolimus.
- •Smoker or user of other nicotine products at the discretion of the investigator.
- •Drug or alcohol abuse or history of drug or alcohol abuse in the past 5 years prior to screening.
- •Any medical condition or other circumstances that in the opinion of the investigator might interfere with the study.
- •Abnormal clinically significant laboratory values, ECG findings, vital signs or physical examination findings as judged by the investigator.
- •Inability to adhere to the protocol including plans to move from the area.
- •Use of any prohibited medication (including dietary supplements and herbal medication) within 2 weeks or 7 half-lives (whichever is longer) of day
- •Any positive result at screening for serum hepatitis B surface antigen (HBsAG), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) I and II.
结局指标
主要结局
Incidence and type of adverse events, severe adverse events and SUSAR
时间窗: Up to 28 days post injection
Phase A: 3 consecutive groups each of 10 subjects. Planned dose of ViscoGel® (provided that the data safety monitoring board deemed the previous dose level to be safe): 25mg, 50mg and 75mg.
次要结局
- Change in HIB antibody serum titer(28 days post vaccination)
研究者
研究点 (2)
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