Can the measles-mumps-rubella vaccine be given to children already at 6 months of age?

Phase 1

• Conditions: Infection with measles, mumps or rubella; MedDRA version: 20.0Level: LLTClassification code 10036654Term: PreventionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001901-18-DK
• Lead Sponsor: The Danish National University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6500

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified