CTRI/2024/01/061632招募中Unknown
A Prospective, Randomized, Single-Center, Two Arm, Open Label, Parallel Group, Comparative Study to Evaluate the Safety of Needle Free Injection System (NFIS) and Immunogenicity of Cervavac HPV Vaccine in Healthy Young Girls using NFIS. ? - NI
IntegriMedical Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1 Healthy young girls of 9 years to 12 years of age on the day of inclusion
- •2 Informed Consent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR)
- •3 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
- •4 Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg)
- •5 Young girls with intact uterus and not pregnant.
- •6 Subject’s willingness and ability to comply with the requirements of the protocol as judged by the investigator
排除标准
- •1 Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •2 Subject has a known history of prior vaccination with HPV vaccine.
- •3 Subject concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens
- •4 Subject with a current diagnosis or prior history of genital warts or treatment of genital warts
- •5 Female subject with current diagnosis or history of treatment for cervical pre-malignancies or malignancy
- •6 Subject has a history of any allergic diseases or severe allergic reaction to any agent
- •7 Subject has had an acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination
- •8 Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired Human Immunodeficiency Virus infection.
- •9 Coagulation disorder that would contraindicate IM injections
- •10 Subject has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- •11 Subject has history of any cancer, organ transplant or any other immune system disease
- •12 Subject has had chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study
- •13 Subject has received any oral or injectable antibiotics and/or antiviral from five days before screening through to enrolment
- •14 Subject has history of receiving a blood transfusion or other blood products in three months prior to screening
- •15 Subject has history of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned during the course of 7-month study period.
- •16 History of any surgical procedure for the removal of the uterus or hysterectomy.
- •17 Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results
- •18 Subjects with a history of convulsions epilepsy other central nervous system diseases severe disease of haematopoietic system decompensated heart disease or impaired renal function
- •19 A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy)
- •20 Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
- •21 Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •22 Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
- •23 Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction
研究者
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