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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
6,540
Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark
Herlev Hospital
Herlev, Denmark
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.
Time frame: 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.
Time frame: 6-12 months of age
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