CTRI/2013/05/003711进行中（未招募）1/2 期
A Randomized, Open Label, Comparative, Single Dose Phase I/II Study to Evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- safety tolerability Incidence intensity causality and relationship to vaccination of solicited adverse events
研究概览
简要总结
Subjects in each group will receive single dose of one of the two (with or without preservative) test vaccines.Subjects will be administered with the study vaccines on Day 0 and will be followed up to Day 28. A blood sample will be collected on Day 0 (Pre-dose), Day 28 (Post dose), for immunogenicity parameters (Anti-Pneumococcal antibodies). Blood and urine sampling for screening and safety analysis will be done for all subjects at screening and Day 28.The aim of our present study is to evaluate the safety, tolerability and immunogenicity of two formulation (with and withought preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male or female Subjects aged 18 to 65 years of age.
- •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 child bearing potential but practicing acceptable method of contraception or surgically sterile.
- •Acceptable methods of contraception are Intra-uterine contraceptive device without hormone release system placed at least 4weeks prior to study drug administration Effective method of barrier contraception like Condom or diaphragm with spermicidal gel/foam/film/cream/suppository.
排除标准
- •1.History of previous vaccination against S.
- •pneumoniae (in the previous 5 years).
- •2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years 3.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •4.Investigator site personnel directly affiliated with this study and their immediate families.
- •Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- •5.Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition.
- •6.Known history of administration of blood or blood-derived products in the past 3 months.
- •Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, lmmunosuppressants or other immune-modifying drugs in past or at any time during the study.
- •8.Febrile illness (temperature ≥38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- •9.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
- •10.Use of any investigational drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •11.Presence of chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment such as would endanger the volunteer or is likely to result in non conformance to the protocol.
- •Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures 13.History or presence of significant asthma, urticaria or other allergic reactions.
- •14.History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- •15.Pregnant and/ or lactating mothers in case of female subjects.
- •16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity 17.Participation in a drug research study within past 3 months.
- •18.Planned participation in another clinical trial during the trial period.
- •19.Subjects planning to leave the area of study before completion of the study.
结局指标
主要结局
safety tolerability Incidence intensity causality and relationship to vaccination of solicited adverse events
时间窗: solicited adverse events local and systemic during the 7 day follow-up period day 0 to 7 after vaccination, 4 weeks follow-up period after vaccination | Incidence, intensity, causality and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period
次要结局
- Immunogenicity- serotype specific Anti Pneumococcal IgG as determined by ELISA and OPA(Seroprotection against Pneumococcal Serotypes at 28+3 days followup post vaccination)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Study of Methotrexate Tablets 2.5 mg in Adult Patients with Inflammatory Disorder of many joints and/or Patches of Abnormal SkiCTRI/2018/11/016245Intas Pharmaceuticals Limited42
已完成
不适用
A Bioequivalence Study of Capecitabine 500 mg with Xeloda® 500 mg in Adult Cancer Patients Under Fed Condition.CTRI/2021/09/036815SP Accure Labs Pvt Ltd33
尚未招募
不适用
A Study to evaluate the blood levels of Lacosamide 200 mg tablets (Mfg. by Eris Lifesciences Ltd) as a Test compared to the Reference MOTPOLY XR Tablets (Lacosamide 200 mg Mfg. by Acuta Pharmaceutical) tablets in a healthy subject under fasting conditionsCTRI/2025/04/084766Eris Lifesciences Ltd24
进行中（未招募）
1 期
A single center, open label,comparitive study to evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy AdultsCTRI/2013/05/003711PANACEA BIOTEC LIMITED48
已完成
1 期
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult SubjectsHealthy SubjectsHuman VolunteersHealthy ParticipantsBioequivalenceNCT05519514Abbott56