MMR at 6 Months Trial (NCT03780179) | Clinical Trial Compass
CompletedPhase 4
MMR at 6 Months Trial
Denmark6,540 participantsStarted 2019-04-15
Plain-language summary
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
Who can participate
Age range5 Months – 7 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.