NCT06331156已完成3 期
A Phase III, Open-label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Porcine Circovirus (PCV)-Free Liquid Formulation of an Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Chinese Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
研究概览
简要总结
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)], who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- •Healthy participants as established by medical history and clinical examination before entering into the study.
- •A male or female of Chinese origin, between and including, 6 and 10 weeks (42-76 days) of age at the time of study enrolment.
- •Born after a gestation period of 36 to 42 weeks inclusive.
排除标准
- •Medical conditions
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Hypersensitivity to latex.
- •History of severe combined immunodeficiency.
- •History of seizures or progressive neurological disease.
- •Family history of congenital or hereditary immunodeficiency.
- •Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception (IS).
- •History of IS.
- •Major congenital defects, or serious chronic illness as assessed by the investigator.
- •Any contraindications to IPV.
- •Previous confirmed occurrence of rotavirus gastroenteritis (RVGE).
- •History of poliomyelitis.
- •Participants with confirmed or suspected Coronavirus Disease 2019 (COVID-19).
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or planned use during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study interventions administration*, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
- •*In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
- •Administration of long-acting immune-modifying drugs from birth or planned administration at any time during the study period.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >=0.5 milligram/kilogram (kg)/day, or equivalent. Inhaled, intra-articular and topical steroids are allowed.
- •Previous vaccination against RV.
- •Previous vaccination against poliomyelitis.
- •Prior/Concurrent clinical study experience
- •- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
- •Other exclusions
- •- Child in care.
结局指标
主要结局
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
时间窗: At Month 3.5 (1 month post-Dose 3 of IPV)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.
次要结局
- Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab(At Month 3.5 (1 month post-Dose 3 of IPV))
- Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64(At Month 3.5 (1 month post-Dose 3 of IPV))
- Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL(At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group))
- Number of Participants Reporting Any Solicited Systemic Events(Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group))
- Number of Participants Reporting Any Unsolicited Adverse Events (AEs)(Within 31 days after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group))
- Number of Participants Reporting Any Serious Adverse Events (SAEs)(From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5))
研究者
研究点 (6)
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