An open-label, Randomized, Controlled Trial to assess Safety and Immunogenicity of qHPV intramuscular Vaccine administered using IntegriMedical® Needle-Free vs. Needle Injection In Healthy Individuals Aged 9-26 years, in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- • Incidence of immediate adverse events 30 minutes after each vaccination
研究概览
简要总结
This Phase IV clinical trial is a prospective, open-label, randomized controlled trial designed to assess the safety and immunogenicity qHPV intramuscular vaccine administered using IntegriMedical needle-free injection system (IM-N-FIS) vs. conventional hypodermic needle CHN injection in healthy individuals aged 9-26 years (both inclusive), in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 9.00 Year(s) 至 26.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be enrolled in the study if they meet all the following criteria:
- •Healthy female and male participants of age 9-26 years (both inclusive) at the time of the screening
- •Clinically healthy, as established by medical history and physical examination before entering the study
- •Female participants with childbearing potential, not pregnant at the time of vaccination
- •Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap) 30 days prior to the enrollment and throughout the study period
- •Able to provide informed consent and assent (whichever applicable)
- •Able to comply with the study requirements.
排除标准
- •Participants will be excluded from the study if they meet any of the following criteria:
- •Previous vaccination against HPV
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period
- •Administration of any other vaccine within 30 days prior to study enrollment, or within 30 days of each study vaccination visits except for routine vaccines like rabies vaccine or tetanus containing vaccine
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period
- •Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
- •History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast
- •Participants with medically stable, well controlled autoimmune disease may be permitted
- •Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- •Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period
- •Acute disease at the time of enrollment.
- •Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- •All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature 37.5 degree Celsius
- •Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.
结局指标
主要结局
• Incidence of immediate adverse events 30 minutes after each vaccination
时间窗: • Incidence of immediate adverse events 30 minutes after each vaccination | • Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination | • Incidence, severity, and relationship of unsolicited adverse events throughout the study period | • Incidence, severity and relationship of serious adverse events throughout the study period | • Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
• Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination
时间窗: • Incidence of immediate adverse events 30 minutes after each vaccination | • Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination | • Incidence, severity, and relationship of unsolicited adverse events throughout the study period | • Incidence, severity and relationship of serious adverse events throughout the study period | • Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
• Incidence, severity, and relationship of unsolicited adverse events throughout the study period
时间窗: • Incidence of immediate adverse events 30 minutes after each vaccination | • Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination | • Incidence, severity, and relationship of unsolicited adverse events throughout the study period | • Incidence, severity and relationship of serious adverse events throughout the study period | • Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
• Incidence, severity and relationship of serious adverse events throughout the study period
时间窗: • Incidence of immediate adverse events 30 minutes after each vaccination | • Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination | • Incidence, severity, and relationship of unsolicited adverse events throughout the study period | • Incidence, severity and relationship of serious adverse events throughout the study period | • Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
• Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
时间窗: • Incidence of immediate adverse events 30 minutes after each vaccination | • Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination | • Incidence, severity, and relationship of unsolicited adverse events throughout the study period | • Incidence, severity and relationship of serious adverse events throughout the study period | • Pain assessment using Visual Analog Scale (VAS) at the time of vaccination
次要结局
- • Geometric Mean Titre of antibodies to HPV types 6, 11, 16, and 18 among participants receiving vaccination either with IM-N-FIS or CHN, 30 days after last dose of vaccination i.e. on Day 210.
研究者
Dr Nitin Shah Kantilal
P.D. Hinduja National Hospital and Medical research Center