A phase-I, open label clinical trial to assess the safety and tolerability ofrecombinant quadrivalent Human Papilloma Virus (qHPV) vaccinemanufactured by Serum Institute of India Pvt.Ltd. in healthy adultvolunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1. Occurrence of immediate adverse events after single dose.
研究概览
简要总结
The study is designed as a single center trial to assess safety and tolerability of SIIPLs qHPV vaccine in healthy adults. A single dose of Quadrivalent HPV vaccine will be administered in healthy adult volunteers. Active follow up for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, follow up for unsolicited AEs and SAEs will be carried out over the period between enrollment and 30 days after vaccination on all subjects by using diary cards. Independent oversight of this study will be provided by a DSMB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult male aged between 18-26 years and female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
- •Healthy subjects as established by personal medical history, physical examination, laboratory investigation during screening and as per the clinical judgment of the Investigator.
- •Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap).
- •Subject’s willingness and ability to comply with the requirements of the protocol.
- •Subject willing to sign a written informed consent.
排除标准
- •History of HPV vaccination or HPV infection
- •Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during trial participation.
- •History of abnormal cervical cancer tests in females or history of genital warts in females and males.
- •History of any surgical procedure for the removal of the uterus or hysterectomy.
- •History of major congenital defects or illness.
- •Investigator site personnel directly affiliated with this study.
- •Acute illness and/or fever at the time of vaccination or during the past 7 days.
- •Administration of corticosteroids, cytotoxic agents or radiotherapy or other immune-modifying drugs in last 3 months.
- •Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment.
- •History of receipt a blood transfusion or other blood products.
- •Use of any investigational or non-registered drug.
- •History of administration of any vaccine in past 30 days or during the study.
- •History of any major illness.
- •History of anaphylactic shock
- •Participant having any allergies to medications and food.
- •History or presence of significant alcoholism, drug abuse in the past one year.
- •History or presence of significant smoking.
- •Reactive serology for HIV, hepatitis B and hepatitis C viruses
- •Abnormal ECG and chest X-ray
- •Participant has any plans to relocate from the area prior to the completion of the study.
- •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
1. Occurrence of immediate adverse events after single dose.
时间窗: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.
2. Occurrence of solicited adverse reactions within 7-day postvaccination
时间窗: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.
follow-up period.
时间窗: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.
3.Occurrence of solicited adverse events within 30 days after vaccination.
时间窗: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30.
次要结局
- 1. Occurrence of unsolicited adverse events, including serious adverse(events within 30 days after vaccination.)