Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection With Unrelated Pathogens and Allergic Diseases - a Single-centre Phase IV RCT With a Factorial Design
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of respiratory infection within the 3 months following randomisation
研究概览
简要总结
The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.
详细描述
The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes.
The current Swiss administration schedule of giving MMR at 9 and 12 months of age ("current schedule") will be compared with a "modified schedule". This is expected to maximise the beneficial non-specific effects of MMR by giving it at 6 and 13 months of age, separately from other vaccines ("modified schedule"). Factorial analysis will enable assessment of the benefit of the intervention on each of the two doses of MMR separately or in combination.
The clinical aims are to determine whether a modified schedule of MMR administration reduces both the risk and severity of: (i) infections with unrelated pathogens and (ii) atopic and allergic diseases.
The laboratory aims are to: (i) quantify and characterise the immunological non-specific effects of MMR, and (ii) identify the biological pathways and molecular mechanisms that are altered by MMR vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •6-month-old children
- •In overall good health, without any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) and no clinically significant abnormal finding on history and/or physical examination
- •Fully immunised for age according to the Swiss vaccination schedule
- •with at least 2 doses of DTP-containing vaccine
- •the last dose of vaccine received at least 2 weeks prior to enrolment
排除标准
- •Contra-indications to MMR, including
- •immunosuppression (i.e. proven, suspected, or planned)
- •allergy to a component of the vaccine
- •receipt of a live-attenuated vaccine in the four weeks prior to inclusion
- •Vaccine refusal
- •Indication for an early MMR vaccination, including
- •Measles outbreak
- •Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment)
- •Travel to a region with a high risk of measles outbreak
- •Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including
- •severe eczema
- •parental will
- •Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
- •Plan to move out of the country or have prolong absence during the trial
- •Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised)
- •Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)
研究组 & 干预措施
C.C. : Both MMR doses given on current schedule (9 months and 12 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
- 9 months (= current Swiss schedule)
- 12 months, concomitant with other vaccines (= current Swiss schedule)
干预措施: Measles-Mumps-Rubella vaccine (MMR) (Biological)
M.C. : 1st MMR on modified schedule (6 months) and 2nd MMR on current schedule (12 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
- 6 months (= modified schedule)
- 12 months, concomitant with other vaccines (= current Swiss schedule)
干预措施: Measles-Mumps-Rubella vaccine (MMR) (Biological)
C. M. : 1st MMR on current schedule (9 months) and 2nd MMR on modified schedule (13 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
- 9 months (= current Swiss schedule)
- 13 months, distant from other vaccines (= modified schedule)
干预措施: Measles-Mumps-Rubella vaccine (MMR) (Biological)
M.M. : Both MMR doses given on modified schedule (6 months and 13 months)
Measles-mumps-rubella (MMR) vaccine 0.5 ml injected intramuscularly, at:
- 6 months (= modified schedule)
- 13 months, distant from other vaccines (= modified schedule)
干预措施: Measles-Mumps-Rubella vaccine (MMR) (Biological)
结局指标
主要结局
Incidence of respiratory infection within the 3 months following randomisation
时间窗: Measured over the 3 months following randomisation
Incidence of parent-reported respiratory infections between 6 months and 9 months of age using fortnightly REDCap questionnaires, with validation of data by confirmation with treating paediatrician and medical records.
次要结局
- Infection: Time to first infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection: Prevalence of infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection: Number of days free of infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection: Number of days free of infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection severity: Hospitalisation for infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection severity: Outcome of infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection severity: Duration of infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection severity: Antibiotic use for infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection severity: Antibiotic use for infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection severity: Outcome of infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection: Time to first infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection: Prevalence of infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection: Incidence of infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection: Incidence of infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Infection severity: Hospitalisation for infection within the 3 months following randomisation(Measured over the 3 months following randomisation)
- Infection severity: Duration of infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
- Incidence of respiratory infection within the 18 months following randomisation(Measured over the 18 months following randomisation)
研究者
Laure Pittet, MD-PhD
Clinical Scientist
Pediatric Clinical Research Platform