Status:
COMPLETED
MMR at 6 Months Trial
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Meales-mumps-rubella Vaccine
Eligibility:
All Genders
5-7 years
Phase:
PHASE4
Brief 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
Eligibility Criteria
Inclusion
- Gestational age of 32+ weeks.
- Birth weight of 1000+ grams.
- Signed informed consent from the parents.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2022
Estimated Enrollment :
6540 Patients enrolled
Trial Details
Trial ID
NCT03780179
Start Date
April 15 2019
End Date
January 7 2022
Last Update
January 13 2022
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100
2
Herlev Hospital
Herlev, Denmark, 2730