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

Inclusion Criteria:

• Gestational age of 32+ weeks.
• Birth weight of 1000+ grams.
• Signed informed consent from the parents.

Exclusion Criteria:

• 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.