Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 6, 10, 14 Weeks and 9 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI
研究概览
简要总结
The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)
详细描述
In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:
Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.
2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
- •Healthy assessed from medical history and physical examination
- •Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
- •Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
- •Parent(s)/guardian(s) granting access to the infant's trial related medical records
- •Parent(s)/guardian(s) likely to comply with the trial procedures
排除标准
- •Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
- •OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial
- •Low birth weight (< 2,500 g)
- •Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
- •Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- •Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
- •Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
- •Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial
- •Participating in another clinical trial
- •Not suitable for inclusion in the opinion of the investigator
结局指标
主要结局
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI
时间窗: Change from baseline to one month after 3rd vaccination
次要结局
- Adverse event following vaccinations (key secondary)(After primary injections at 2, 4 and 6 months of age)
- Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody(One months after 3rd vaccination)
- Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3(Before and one month after the 4th vaccination)
- Subjects with seroprotection against poliovirus types 1, 2 and 3(Before and one month after the 4th vaccination)
- Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3(From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination)