MMR at 6 Months Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03780179|
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : January 13, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Meales-mumps-rubella Vaccine||Biological: MMRvaxpro Biological: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6540 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization to intervention: MMRvaxpro at 6 months of age, or placebo-vaccine (solvent only)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||January 7, 2022|
|Actual Study Completion Date :||January 7, 2022|
|Placebo Comparator: Placebo||
- Humoral immunogenicity [ Time Frame: 1 months after intervention ]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 [ Time Frame: 6-12 months of age ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||5 Months to 7 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Gestational age of 32+ weeks.
- Birth weight of 1000+ grams.
- Signed informed consent from the parents.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780179
|Copenhagen, Copenhagen Ø, Denmark, 2100|
|Herlev, Denmark, 2730|
|Responsible Party:||Lone Graff Stensballe, Pediatrician, associate professor, PhD, Rigshospitalet, Denmark|
|Other Study ID Numbers:||
|First Posted:||December 19, 2018 Key Record Dates|
|Last Update Posted:||January 13, 2022|
|Last Verified:||January 2022|
|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|
RNA Virus Infections