CTRI/2024/08/072040尚未招募2 期
Antibody Response following One Dose of Cervavac® as compared to One Dose of Gardasil® Vaccine in Healthy Girls Aged 9-14 Years: A Non-inferiority, Multicenter, Double-blind, Randomized Controlled trial - Academic HPV Vaccine Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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 girl volunteers aged 9-14 years, determined by clinical history and examination
- •2)Any one parent of the volunteer, is willing and able to sign the informed consent form
- •3)Volunteers willing to provide verbal assent and if 12 years and older are willing to sign the assent form
- •4)Volunteers and parent/s are willing and able to comply with the requirements of the protocol, as judged by the investigator
排除标准
- •1)Known history of prior vaccination with any HPV vaccine
- •2)History of allergic reactions to any vaccines or vaccine components
- •3)An acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination or receipt of any oral or injectable antibiotics and/or antivirals seven days before screening (Temporary exclusion; participant can be rescreened after 7 days of convalescence period)
- •4)History of coagulation disorder that is a contraindication for intramuscular injections.
- •5)History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological abnormality, mental or physical disability, blood dyscrasia, cancer, organ transplant, immune disorder, HIV infection or any condition which in the opinion of the investigator might interfere with the evaluation of the study
- •6)Administration 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.
- •7)History of transfusion of blood or blood products in the previous 3 months
- •8)History of or plan for administration of any non-study vaccine pre or post 30 days of administration of the study vaccine (Temporary exclusion; participant can be rescreened after 30 days of administration of any non-study vaccine)
- •9)Girl with menarche having her last menstrual period (LMP) more than 2 weeks from screening or inability to recall LMP (Temporary exclusion; participant can be rescreened within two weeks after the next menses)
- •10)Any health condition as determined by medical history and / or physical examination/ or lab investigations at the time of screening, which in the judgment of the ‘Investigator’ might compromise the participant’s health and safety
- •11)Any other condition/situation as determined at screening, which, in the judgment of the ‘ Investigator’ might compromise the participation in the study
研究者
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