The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively: non-inferiority (NI) of the percentage of participants with predefined serotype-specific immunoglobin G (IgG) concentrations after Dose 3 and NI of IgG geometric mean concentrations (GMCs) after Dose 4. All 20 serotypes met the co-primary objective of NI of IgG GMCs after Dose 4. Fourteen of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined IgG levels after Dose 3 (two serotypes missed by a wider margin while four narrowly missed), and all serotypes met noninferiority for the key secondary objective of IgG GMCs after Dose 3. All 20 serotypes elicited robust functional responses (OPA) and increases in antibody responses after Dose 4, with the totality of data supporting the potential benefit of all serotypes in this 20-valent vaccine candidate.
'We are encouraged by today's data which show that if approved for a pediatric indication, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine,' said
Overall, the safety profile of the 20vPnC candidate was consistent with Prevnar 13 given in the same schedule. A similar percentage of infants receiving either vaccine experienced local reactions (pain at the injection site, redness, and swelling), fever, and other systemic events (decreased appetite, drowsiness, and irritability). The study also met non-inferiority objectives for responses to co-administered routinely used pediatric vaccines.
Based on the totality of positive safety and immunogenicity data,
About the 20vPnC Phase 3 Pediatric Program
In 2020,
A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to Prevnar 13 in infants vaccinated at 2, 4, 6, and 12-15 months of age in the
A Phase 3 study describing the tolerability and safety of 20vPnC, with Prevnar 13 serving as the control in infants vaccinated at 2, 4, 6, and 12-15 months of age in multiple countries. (NCT04379713)
A Phase 3 study describing the tolerability and safety and comparing immunogenicity of 20vPnC to Prevnar 13 in infant vaccination at approximately 2, 4, and 11-12 months of age in
A Phase 3 study in children 15 months through
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