MMRvaxpro
BiologicalMMRvaxpro vaccine
NCT Number: NCT03780179
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
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Notify Me5 month–7 month
All sexes
Interventional
Phase 4
Rigshospitalet, Copenhagen, Copenhagen Ø, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MMRvaxpro vaccine
Placebo
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.
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.
Rigshospitalet, Denmark
Other
Measles-mumps-rubella Vaccine at 6 Months of Age, Immunology, and Childhood Morbidity in a High-income Setting
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.