A Phase 4 single arm multicentric study to assess the safety of SIIPL qHPV vaccine CERVAVAC when administered in a two dose schedule to girls and boys aged 9 to 14 years and in a three dose schedule to women and men aged 15 to 26 years
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
- 试验地点
- 23
- 主要终点
- 1) Incidence, severity, and relationship of local and systemic solicited adverse events (AE) up to 7 days following each vaccination.
研究概览
简要总结
A Phase-IV single arm, multicentric, active study with a primary objective to assess the safety of SIIPL’s qHPV vaccine (CERVAVAC®) when administered as a two-dose schedule (0 and 6 months) to girls and boys aged 9-14 years and as a three-dose schedule (0, 2 and 6 months) to women and men aged 15-26 years. A total of 2000 subjects, 1000 subjects in each of the age cohorts, 9-14 years, and 15-26 years will be enrolled in the study. 0.5-ml suspension of CERVAVAC vaccine will be administered as an Intramuscular (IM) injection in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Subjects will be followed up till one month post the last dose of study vaccine with the duration of study participation for each subject being at least 7 months. Assessment of incidence, severity, and relationship of local and systemic solicited adverse events up to 7 days following each vaccination, unsolicited adverse events occurring up to end of study visit (Day 210), and serious adverse events (SAE) occurring up to end of study visit (Day 210) will be done in the study.
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
- 9.00 Year(s) 至 26.00 Year(s)（—）
- 性别
- All
入选标准
- •Female and male subjects aged 9-26 years.
- •Subjects who are eligible for receiving CERVAVAC vaccine according to the approved local prescribing information and as per the Investigator’s opinion.
- •3.Subject’s or their parent’s willingness and ability to comply with the requirements of the protocol.
- •4.Subject willing to sign a written informed consent.
- •Either of the parent is willing to sign written informed consent form for subject less than years of age and subject is willing to sign written assent form.
排除标准
- •1.Subject who has a known history of prior vaccination with HPV vaccine.
- •Subject who was previously enrolled in HPV vaccine surveillance and had received a similar active agent.
- •3.Subject who had received any investigational product within 30-days prior to their first visit.
- •4.Hypersensitivity to the active substances or to any of the excipients of the vaccine including severe allergic reactions to yeast, a vaccine component.
- •5.Pregnant females or females planning to become pregnant during the study duration.
- •6.Any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.
结局指标
主要结局
1) Incidence, severity, and relationship of local and systemic solicited adverse events (AE) up to 7 days following each vaccination.
时间窗: 1) Local and systemic AE up to 7 days. | 2) Unsolicited AE up to day 210. | 3) SAEs up to day 210.
2) Incidence, severity, and relationship of unsolicited adverse events (AE) occurring up to end of study (EOS) visit (Day 210).
时间窗: 1) Local and systemic AE up to 7 days. | 2) Unsolicited AE up to day 210. | 3) SAEs up to day 210.
3) Incidence, severity, and relationship of serious adverse events (SAE) occurring up to end of study (EOS) visit (Day 210).
时间窗: 1) Local and systemic AE up to 7 days. | 2) Unsolicited AE up to day 210. | 3) SAEs up to day 210.
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Hitt Sharma
Serum Institute of India Pvt Ltd