Merck & Company announced that its investigational 15-valent pneumococcal conjugate vaccine was “noninferior” to a currently available 13-valent pneumococcal conjugate vaccine in healthy babies 6 to 12 weeks of age.
The Phase II study, called V114-008, met its primary endpoint, showing noninferiority for the 13 serotypes seen in both vaccines. V114 also caused an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which aren’t in PCV13.
Pneumococcal disease is caused by Streptococcus pneumoniae, and includes non-invasive illnesses like pneumonia, sinusitis, and middle ear infection. It also causes invasive diseases such as bacteremia, bacteremic pneumonia, and meningitis. Everyone is at risk for pneumococcal disease, but the most vulnerable populations are children under the age of 2, adults 65 years and older, and people with suppressed immune systems or chronic diseases.
The U.S. Food and Drug Administration (FDA) granted V114 Breakthrough Therapy Designation in January 2019. That decision was in part due to data from this trial and another Phase I/II trial, V114-005.