CTRI/2017/06/008776已完成1 期
A single arm open label non-comparative Phase-I study to evaluate safety, reactogenicity and immunogenicity of single intramuscular dose of 14-valent pneumococcal polysaccharide conjugate vaccine (with thiomersal as preservative) of Biological E. Limited in 18-45 year-old healthy adults. - None
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
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 subjects between 18-45 years of age at the time of vaccination;
- •2.Subjects who provide voluntary written informed consent to participate in the study and are capable of comprehending and complying with study requirements and procedures, able and willing to complete subject diary and to return for all scheduled follow-up visits, and have expressed availability for the required study period, with access to a consistent means of telephone contact, either residential land line or mobile.
- •3.Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history and clinical assessment;
- •4.Adult male subjects willing to follow acceptable methods of contraception (e.g. condom, with or without spermicide) or practice abstinence and agreeing not to make their female partners pregnant from the time of vaccination until the end of the study.
- •5.No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
- •6.Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
排除标准
- •1.Previous history of pneumococcal vaccination;
- •2.History of Invasive Pulmonary Disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or any culture-confirmed invasive disease caused by S. pneumoniae;
- •3.History of allergic or anaphylactic reaction to any vaccine or vaccine-related component or known hypersensitivity to any component of the study vaccine.
- •4.Any acute or serious infection needing systemic antibiotics or antiviral treatment in last 7 days;
- •5.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or haematological functional abnormality or major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
- •6.Epilepsy, a history of seizures or convulsions, or a family history of mental illness;
- •7.History of any coagulation or other blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) or receipt of anti-coagulants in the past 3 weeks;
- •8.Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
- •9.Any licensed or investigational drug or vaccine administered within the 90 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine;
- •10.Known or suspected immunosuppression or immunodeficiency;
- •11.Any laboratory abnormality that could increase the risk associated with study participation or interfere with the interpretation of study results;
- •12.Inability or unwillingness to abide by the requirements of the study;
- •13.Any participant who cannot be adequately followed for safety, reactogenicity and immunogenicity according to the study plan;
- •14.Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;
- •15.Suspicion or recent history (within the past year) of alcohol or substance abuse.
- •16.An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
- •17.Any medical or social condition that in the opinion/judgement of the investigator will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow up.
研究者
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