CTRI/2025/07/090243尚未招募1 期
A Phase-I, open label clinical trial to assess the safety and immunogenicity of Quadrivalent Human Papillomavirus (HPV) vaccine in healthy subjects.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the safety and reactogenicity of a test vaccine.
研究概览
简要总结
This is a Phase-I, prospective, FIH, open label clinical study of HPV vaccine with objective to evaluate the safety, reactogenicity, and immunogenicity of Quadrivalent HPV vaccine of Cadila Pharmaceuticals Limited, India in healthy, adult female subjects.
Safety and reactogenicity will be evaluated based on the solicited and unsolicited AEs post each vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy adult female subjects aged between 18-45 years.
- •2.BMI within normal limit of 18.50-30.00 kg/m2 (inclusive both).
- •3.Subjects in good health at screening and enrollment into the study.
- •4.As per investigator, subjects should be eligible to participate in the study including ability to provide written informed consent and comply with all study requirements.
- •5.Documented negative test for HIV-1/2, HBsAg and HCV.
- •6.Sexually active subjects willing to use an effective method of contraception during the entire study.
- •7.Female subjects having a negative urine pregnancy at screening visit.
排除标准
- •1.History of HPV vaccination or wart or condyloma or cervical intraepithelial neoplasia (CIN) / abnormal cervical cancer tests in females.
- •2.History of adverse reactions including allergy or hypersensitivity reaction to any vaccine.
- •3.Acute illness and/or fever at the time of vaccination or during the past 7 days.
- •4.History of disease or any underlying medical conditions, any drug intake in the past two weeks of proposed vaccination date.
- •5.Subject with known or suspected immunodeficiency or an auto-immune disease.
- •Subjects using any immunosuppressive therapy, use of nontopical antiviral therapy with activity against herpes virus.
- •7.Any vaccine administration within the last 30 days or planned to be administered during the study period.
- •8.Pregnant and lactating female subjects.
- •9.Subjects with diabetes.
- •10.Subjects with any serious medical condition in last 6 months.
- •11.Participation in another interventional clinical trial during the past 3 month prior to screening.
- •12.Any clinically significant abnormal laboratory values, ECG or chest X-Ray findings.
- •13.History or presence of significant alcoholism, drug abuse in the past 1 year.
- •14.History or presence of significant smoking.
- •15.Subject has any plans to relocate from the area prior to the completion of the study.
- •16.Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study.
结局指标
主要结局
To evaluate the safety and reactogenicity of a test vaccine.
时间窗: Till Day 30 days post-vaccination
次要结局
- To evaluate the immunogenicity results of the test vaccine.(On Day 30 after vaccination)
研究者
Dr Arani Chatterjee
Cadila Pharmaceuticals Limited
研究点 (1)
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