Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6,540
- 试验地点
- 4
- 主要终点
- Hospitalisation for infection
研究概览
简要总结
Randomised, double-blind clinical trial to test humoral and cellular immunogenicity, and potential in-direct beneficial effect of the MMRvaxpro-vaccine administered at 6 months of age
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 32+ weeks.
- •Birth weight of 1000+ grams.
- •Signed informed consent from the parents.
排除标准
- •Immune-deficiency (primary or acquired) or -suppression.
- •Intake of immune modulating medicine (including high doses of corticosteroids) (M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids, e.g. for asthma prophylaxis or replacement therapy).
- •Signs of severe illness or major malformation.
- •No Danish-speaking parent.
- •Children with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion are excluded.
- •Children with known fructose intolerance, thrombocytopenia or any coagulation disorder will be excluded.
- •Children who received blood or plasma transfusions, or administration of human immune serum globulin within the last 3 months will be excluded.
- •Further, children are excluded from the trial if any contraindication is suspected: history of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin.
- •Children with active untreated tuberculosis, blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems will be excluded.
结局指标
主要结局
Hospitalisation for infection
时间窗: 6-12 months of age
Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts.
Humoral immunogenicity
时间窗: 1 months after intervention
The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be \>120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme.
次要结局
未报告次要终点
研究者
Lone Graff Stensballe
Pediatrician, associate professor, PhD
Rigshospitalet, Denmark