Topline results were announced from a phase 3 study evaluating the safety, tolerability and immunogenicity of the 15-valent pneumococcal conjugate vaccine (Vaxneuvance™) in healthy infants.
Vaxneuvance consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease. The multicenter, randomized, double-blind, active-comparator-controlled PNEU-PED study (ClinicalTrials.gov Identifier: NCT03893448) included 1720 healthy infants enrolled at 42 to 90 days of age. Patients were randomly assigned to receive a total of 4 doses of 0.5mL intramuscular injections of Vaxneuvance or PCV13 (Prevnar 13) at 2, 4, 6, and 12 to 15 months of age.
Results showed that the trial met its primary and key secondary endpoints. Vaxneuvance was found to be noninferior to PCV13 for all 13 shared serotypes at 30 days following the third dose (based on serotype-specific response rates) and for 12 of the 13 shared serotypes (based on serotype-specific immunoglobulin G geometric mean concentrations). At 30 days following the fourth dose, Vaxneuvance was found to be noninferior to PCV13 for all 13 shared serotypes (based on serotype-specific immunoglobulin G geometric mean concentrations).
Compared with PCV13, statistically superior immune responses were observed with Vaxneuvance for shared serotype 3 and serotypes 22F and 33F. Patients administered Vaxneuvance or PCV13 also demonstrated noninferior immune responses to antigens contained in several routinely used pediatric vaccines when concomitantly administered.
The safety profile of Vaxneuvance was generally comparable to PCV13 following any dose. Full study results from PNEU-PED, along with the phase 3 PNEU-LINK study (ClinicalTrials.gov Identifier: NCT03692871) in healthy infants, will be presented at an upcoming scientific congress.
Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said: “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.”
In July 2021, the Food and Drug Administration (FDA) approved Vaxneuvance for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
The Company expects to submit a supplemental regulatory licensure application to the FDA for use of Vaxneuvance in children before the end of the year.
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). News release. Merck & Co., Inc. Accessed August 25, 2021. https://www.businesswire.com/news/home/20210825005054/en/Merck-Announces-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-Met-Key-Immunogenicity-and-Safety-Endpoints-in-Phase-3-Pivotal-Trial-Evaluating-Use-in-Infants-PNEU-PED-V114-029.