Pfizer Reports Results of 20vPnC in P-III Trial for the Prevention of Invasive Pneumococcal Disease
Shots:
- The P-III study evaluated the tolerability, safety & immunogenicity of 20vPnC vs Prevnar 13 in infants vaccinated at age 2/4/6/12-15mos. across the US for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes in vaccines
- The two co-primary objectives of the study were NI of the percentage of participants with predefined serotype-specific IgG concentrations after the 3rd dose & Ni of IgG GMCs after the 4th dose. All 20 serotypes met the co-primary objective of NI after the 4th dose, 14 met NI after the 3rd dose, whereas all serotypes met the NI secondary objective of IgG GMCs after the 3rd dose
- Pfizer plans to submit an sBLA based on the positive safety & immunogenicity data by the end of 2022 along with the results from the clinical trial expected to be read out by the H2’22
Ref: Businesswire | Image: Pfizer
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