Merck announced topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in healthy infants enrolled between 42-90 days of age (n=1720). In the trial, infants were given a 4-dose regimen of either VAXNEUVANCE or the licensed 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4, 6, and 12-15 months of age.
In the PNEU-PED study, primary endpoints demonstrated:
- VAXNEUVANCE had a safety profile generally comparable to PCV13 following receipt of any vaccine dose.
- At 30 days following the third dose in the series (PD3), VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes based on serotype-specific response rates (proportions of individuals achieving the accepted immunoglobulin G (IgG) threshold value of 0.35mcg/mL) and for 12 of the 13 shared serotypes based on serotype-specific IgG geometric mean concentrations (GMCs).
- The lower bounds of the two-sided 95 percent confidence intervals (CI) for the serotype-specific IgG GMC ratios were greater than 0.5 for 12 shared serotypes; the lower bound was 0.48 for serotype 6A, narrowly missing non-inferiority criteria.
- At 30 days following the fourth (toddler) dose (PD4), VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes based on serotype-specific IgG GMCs.
Secondary endpoints demonstrated statistically superior immune responses for VAXNEUVANCE in comparison to PCV13 for shared serotype 3 and unique serotypes 22F and 33F based on prespecified criteria, as well as non-inferior immune responses to antigens contained in several routinely used pediatric vaccines when administered concomitantly with VAXNEUVANCE or PCV13.
“By nature, pneumococcal disease is constantly evolving. Strains of the disease associated with invasiveness cause significant disease burden in children, calling for innovation to help protect this vulnerable population worldwide,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “At Merck, our goal is to design pneumococcal vaccines that target strains causing the greatest proportion of disease while maintaining a strong immune response to these serotypes. With the inclusion of serotypes 22F and 33F, VAXNEUVANCE has the potential to play an important role in the prevention of invasive pneumococcal disease in children.”
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