Two phase 3 pediatric clinical trials of Merck's 15-valent pneumonia vaccine V114 reach dual primary endpoints

Recently, Merck & Co.
Inc.
announced that its research 15-valent pneumococcal conjugate vaccine V114 has reached the primary endpoints of immunogenicity and safety in two phase 3 pediatric clinical trials
.

In the first interchangeability study for healthy infants aged 42 to 90 days, the immune response results of patients who received a four-dose series of PCV13 vaccine and patients who received a PCV13 mixed dose regimen and then vaccinated with V114 showed that the immune response of 13 serotypes or For pneumococcal disease strains, the effects of the two vaccines are comparable
.

In the supplementary study, Merck said that V114 is used for supplemental vaccination programs for healthy children aged 7 months to 17 years who have not previously been vaccinated with pneumococcal vaccine, or have previously received part or all of the PCV treatment program.
, V114 has 13 common serotypes, and the immune response of this vaccine is usually equivalent to that of PCV13
.

The V114 Phase III clinical development plan includes 16 trials to study the safety, tolerability and immunogenicity of V114 in various populations at increased risk of pneumococcal disease, including healthy elderly and children, and immunity People with certain chronic diseases who are underweight or suffering from pneumococcal bacteria
.

In January of this year, the vaccine also obtained the FDA’s BLA application and priority review designation, and it was decided to be supported by the results of a number of phase 2 and phase 3 clinical studies of V114 in the adult population.
The scope of application of the vaccine is healthy adults and People at increased risk include adults with chronic diseases, adult HIV carriers, and elderly people 65 years of age and older
.

In terms of competitors, Pfizer Prevnar 13 has been the world's best-selling vaccine for many years
.

       Reference source:

       1.

       2.