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
研究组 & 干预措施
IPV SSI
IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
干预措施: IPV SSI (Biological)
IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
干预措施: IPV-Al SSI (Biological)
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)
- Subjects with seroprotection against poliovirus types 1, 2 and 3(One months after 3rd vaccination)
- Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3(One months after 3rd vaccination)