MMR at 6 Months Trial

Rigshospitalet

Status and phase

Completed

Phase 4

Conditions

Meales-mumps-rubella Vaccine

Treatments

Biological: MMRvaxpro

Biological: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03780179

LGS.MMR.01.2016.2022

Details and patient eligibility

About

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

Enrollment

6,540 patients

Sex

All

Ages

5 to 7 months old

Volunteers

No Healthy Volunteers

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.