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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03780179
Other study ID # LGS.MMR.01.2016.2022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 15, 2019
Est. completion date January 7, 2022

Study information

Verified date January 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 6540
Est. completion date January 7, 2022
Est. primary completion date January 7, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Months to 7 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MMRvaxpro
MMRvaxpro vaccine
Placebo
Placebo

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen Copenhagen Ø
Denmark Herlev Hospital Herlev

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Humoral immunogenicity The plaque reduction neutralisation test (PRNT), which measures the serum dilution capable of preventing 50% of plaque formation induced by measles virus in cell cultures, has been considered the most reliable criterion for the serologic evaluation of measles immunity. For PNRT, the protective cutoff titer is defined to be >120. A frequency of 95% seroconversion rate, i.e. children mounting a protective level of humoral immunity according to the abovementioned cutoff value after MMR-vaccination at 6 M of age will be considered sufficient to suggest implementation of MMR at 6 M in the Danish vaccination programme. 1 months after intervention
Primary Hospitalisation for infection Significant decrease in hospitalisation for infection measured as repeated events from 6 to 12 months of age in children randomised to MMR at 6 M compared to children randomised to placebo. Information about hospitalisation for infection will be obtained from the national Danish Patient Register, where all Danish inhabitants are followed-up during all hospital contacts. 6-12 months of age