The trial will cover a cohort of 600 adults aged 65+, taken from last year’s COVID-19 Phase 3 vaccine trial.
Having received their second dose of the COVID-19 vaccine at least six months ago, participants will be randomized into groups to receive either a COVID-19 booster with 20vPnC; a placebo COVID-19 shot with 20vPnC; or a COVID-19 vaccine with placebo 20vPnC.
The primary objective of the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.
The Pfizer/BioNTech COVID-19 vaccine received authorization for emergency use from the US and EU in December, among a number of other markets since.
The 20vPnC vaccine has been developed for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. In February, Pfizer submitted a Marketing Authorization Application for the vaccine in the EU, while the candidate is under priority review for a biologics license application in the US.
More than half the cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine, according to Pfizer.