MMR at 6 Months Trial

Study Overview
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Brief Summary
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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

Official Title
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Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting

Conditions
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Meales-mumps-rubella Vaccine

Intervention / Treatment
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* Biological: MMRvaxpro
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMRvaxpro<br> | Biological: MMRvaxpro<br>* MMRvaxpro vaccine<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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measles-mumps-rubella vaccine