Back to resultsMMR at 6 Months Trial
Primary Purpose
Meales-mumps-rubella Vaccine
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
MMRvaxpro
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Meales-mumps-rubella Vaccine focused on measuring measles-mumps-rubella vaccine
Eligibility Criteria
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.
Sites / Locations
- Rigshospitalet
- Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MMRvaxpro
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03780179
First Posted
December 17, 2018
Last Updated
January 12, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03780179
Brief Title
MMR at 6 Months Trial
Official Title
Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
January 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meales-mumps-rubella Vaccine
Keywords
measles-mumps-rubella vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMRvaxpro
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
MMRvaxpro
Intervention Description
MMRvaxpro vaccine
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Humoral immunogenicity
Description
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.
Time Frame
1 months after intervention
Title
Hospitalisation for infection
Description
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.
Time Frame
6-12 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
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MMR at 6 Months Trial
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