By Colin Kellaher
Pfizer Inc. (PFE) on Monday reported positive preliminary results from a phase 2 proof-of-concept study of its 20-valent pneumococcal conjugate vaccine candidate in infants.
The New York drug maker said the initial three doses in the four-dose study showed preliminary evidence that the vaccine candidate in infants has an overall safety profile similar to Pfizer's Prevnar 13 vaccine.
Pfizer said the findings should support the program's advancement to phase 3 studies, adding that it will discuss phase 3 plans with regulators once data with the fourth dose are available.
Pfizer said the study is assessing the safety and immunogenicity of the 20vPnC candidate for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants.
The 20vPnC candidate includes the 13 serotypes contained in Prevnar 13, plus seven additional Streptococcus pneumoniae serotypes that represent prevalent circulating global disease strains, the company said.
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