CTRI/2021/09/036860已完成3 期
A Randomized, Double-blinded, Multicenter Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Adults
GCChemie Pharmie Ltd0 个研究点目标入组 268 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
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
- •Subjects aged between 18 to 65 years;
- •Subjects willing to give written informed consent prior to the study entry;
- •Subjects with good health as determined by:
- •Medical history;
- •Physical examination;
- •Clinical judgment of the investigator.
- •Subjects able to attend all scheduled visits and comply with all study procedures.
排除标准
- •Subjects administered with any pneumococcal vaccine before vaccination;
- •Subjects with history of pneumococcal infection;
- •Women in pregnancy or lactation period in trial period;
- •Subjects with allergic history or any SAE after vaccination,such as allergy, urticaria, dyspnoea, angioedema
- •Subjects with known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive;
- •Subjects with functional or anatomic asplenia;
- •Patients treated with chemotherapy in past 5 years or administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in 6 months preceding the vaccine trial;
- •Subjects with receipt of blood or blood-derived products in 3 months preceding vaccination;
- •Subjects participating in another clinical study investigating a vaccine or drug in 30 days preceding vaccination;
- •Subjects with receipt of any live virus vaccine in 30 days preceding vaccination;
- •Subjects with receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination;
- •Subjects with thrombocytopenia or bleeding disorder;
- •Subjects with history of asthma, angioneurotic edema, diabetes mellitus or malignancy tumour;
- •Subjects with history of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
- •Subjects with hypertension or whose blood pressure is still above 145/95mmHg even with drug treatment;
- •Subjects with history of eclampsia, epilepsia or psychosis;
- •Subjects with febrile illness (temperature ââ?°Â¥ 38Ã?°C) in 3 days or any acute illness/infection in 7 days preceding vaccination;
- •Subjects with anti-tuberculosis prophylaxis or therapy in progress;
- •Those who cannot fulfil the protocol or cannot sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment
研究者
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