CTRI/2010/091/000032已完成2 期
A randomized, double blind, comparative, phase II/III study to evaluate the immunogenicity and safety of three formulations (15mcg without adjuvant and 7.5mcg with adjuvant and 3.75mcg with adjuvant) of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults. - H1N1 Adult
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
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 volunteers aged 18 years and above.
- •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;
- •?Of child bearing potential but practicing acceptable method of contraception or surgically sterile.
- •?Acceptable methods of contraception are:
- •ï??Intra-uterine contraceptive device without hormone release system (placed at least 4weeks prior to study drug administration.
- •ï??Effective method of barrier contraception like condom or diaphragm with spermicidal gel/foam/film/cream/suppository
排除标准
- •1.Cases, cured cases and contact of influenza A (H1N1) virus
- •2.Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, thiomersal, squalene.
- •3.Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- •4.Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
- •5. Uncontrolled Diabetes mellitus (type I or II),
- •6.History of thyroidectomy or thyroid disease that required medication within the past 12 months
- •7.Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- •8.Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
- •9.Subjects with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy .Seizure disorder other than:
- •a.Seizures secondary to alcohol withdrawal more than 3 years ago, or
- •b.A singular seizure not requiring treatment within the last 3 years
- •10.Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- •11.Guillain-Barre Syndrome
- •12.History of any blood/ blood derived products or seasonal influenza vaccine administration within 3 months before the dosing
- •13.Administration of any other investigational research agents as well as any live attenuated vaccine within 30 days before the dosing
- •14.Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
- •15.Currently receiving anti-TB prophylaxis or therapy
- •16.Oral temperature 37.0 centigrade at the time of dosing
- •17.Psychiatric condition that precludes compliance with the protocol:
- •a.Past or present psychoses
- •b.Past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years
- •c.Disorder requiring lithium
- •d.Suicidal ideation occurring within five years prior to enrollment
- •18.Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteers ability to give informed consent
- •19.Evidence of acute illness within past 7 days prior to enrollment requiring systemic antibiotic or antiviral therapy
- •20.Subjects with pre-existing autoimmune illnesses like rheumatoid arthritis, lupus, multiple sclerosis etc.
- •21.Presence of significant cardiovascular, hepatic, renal, pulmonary (including respiratory depression or diseases involving obstruction/ narrowing of airways), gastrointestinal, endocrine, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment that in the opinion of the investigator, are likely to interfere with study outcome or study subject safety.
- •22.Chronic administration (defined as more than 14 days) of high doses of
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