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Pfizer has begun enrollment in three Phase III trials evaluating 20-Valent pneumococcal conjugate vaccine in adults.

Read time: 1 mins
Last updated:18th Apr 2019
Published:18th Apr 2019
Source: Pharmawand

Pfizer Inc. announced at the end of 2018, the initiation of a Phase III program for its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.

Pfizer now has begun enrollment in three Phase III trials (NCT03828617, NCT03835975 and NCT03760146) evaluating 20vPnC ( 20-valent pneumococcal conjugate vaccine) in adults. Combined, these three trials will enroll more than 6,000 adult subjects, including populations of vaccine-na�ve adults and adults with prior pneumococcal vaccination.

Pfizer�s Phase III pivotal development program for 20vPnC includes three clinical trials in populations of vaccine-na�ve adults and adults with prior pneumococcal vaccination. The pivotal Phase III trial is enrolling an estimated 3,880 adults and is designed to compare immune responses after 20vPnC administration to responses in control subjects greater than 60 years old receiving 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine; evaluate the immunogenicity of 20vPnC in adults 18-59 years of age; and describe the 20vPnC safety profile in adults greater than 18 years old. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03760146.

Another Phase III trial was initiated on February 12, 2019 and is planned to enroll an estimated 875 adults. It is designed to describe the safety and immunogenicity of 20vPnC in adults 65 years of age or older with prior pneumococcal vaccination. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03835975.

A third Phase III trial was initiated on February 14, 2019, and is planned to enroll an estimated 1,610 adults. The study is designed to provide additional safety data and evaluate three different lots of 20vPnC in adults 18 through 49 years of age. More on the study can be found on www.clinicaltrials.gov under the identifier NCT03828617.

Comment; 20-Valent pneumococcal conjugate vaccine is a broader vaccine than Prevnar 13 to protect against more strains of the disease that will compete against Merck's 23-valent Pneumovax (pneumococcal vaccine polyvalent).

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