Measles-mumps-rubella vaccine at 6 months of age, immunology, and childhood morbidity in a high-income setting - The 6 months MMR Trial

The Danish National University Hospital Rigshospitalet0 个研究点目标入组 6,500 人开始时间: 2016年10月24日最近更新: 2022年2月1日

适应症

试验速览

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•Gestational age of 32+ weeks, birth weight of 1000+ grams, signed informed consent from the parents.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 6500
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Immune-deficiency (primary or acquired) or –suppression, and/or 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.

发起方

The Danish National University Hospital Rigshospitalet