Merck's 15-Valent Pneumococcal Conjugate Vaccine Vaxneuvance Meets Primary Endpoints in Phase 3 Trial in Infants

On August 25, 2021, MSD announced that its 15-valent pneumococcal conjugate vaccine, Vaxneuvance, met the primary endpoint in the pivotal Phase 3 clinical trial PNEU-PED, which enrolled healthy infants aged 42 to 90 days.

Pneumococcal disease is caused by *Streptococcus pneumoniae* infection. Its impact on children differs from that on adults, with children under 2 years of age being particularly susceptible to pneumococcal infection. Certain pneumococcal serotypes pose a greater threat to children, including serotypes 22F, 33F, and 3, which account for more than one-quarter of all invasive pneumococcal disease cases in children under 5 years of age.

Vaxneuvance is a 15-valent pneumococcal conjugate vaccine consisting of purified capsular polysaccharides of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, each conjugated to the CRM197 carrier protein. Vaxneuvance has been approved by the FDA for the prevention of invasive disease caused by the pneumococcal serotypes contained in the vaccine in adults aged 18 years and older. Vaxneuvance previously received Breakthrough Therapy designation from the US FDA for the prevention of invasive pneumococcal disease in pediatric patients aged 6 weeks to 18 years.

This multicenter, randomized, double-blind, active-controlled PNEU-PED trial was designed to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of Vaxneuvance in healthy infants aged 42 to 90 days at enrollment (n=1720).

The trial met the primary safety and immunogenicity endpoints:

Across all vaccine doses, the safety profile of Vaxneuvance is comparable to that of the approved 13-valent pneumococcal conjugate vaccine (PCV13).

At 30 days after the third dose, based on serotype-specific response rates, the immunogenicity of Vaxneuvance met the non-inferiority criteria for the 13 pneumococcal serotypes shared by both vaccines.

At 30 days after the third dose, based on the assessment of serotype-specific IgG geometric mean concentration (GMC), the immunogenicity of Vaxneuvance against 12 of the 13 shared serotypes met the noninferiority criteria.

At 30 days after the fourth dose, Vaxneuvance met the noninferiority criteria based on serotype-specific IgG GMCs for all 13 serotypes shared by the two vaccines.

Additionally, the trial also met its secondary endpoint, with Vaxneuvance demonstrating a statistically superior immune response compared to PCV13 for the shared serotype 3 and the unique serotypes 22F and 33F included in Vaxneuvance.

References:

[1] Vaxneuvance Also Met Key Safety Objectives in the Phase 3 PNEU-LINK (V114-031) Study in Infants. Retrieved August 25, 2021, from https://www.merck.com/news/merck-announces-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-met-key-immunogenicity-and-safety-endpoints-in-phase-3-pivotal-trial-evaluating-use-in-infants-pneu-ped-v114-029/

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