V114 pneumococcal vaccine safe and well tolerated among healthy infants

Streptococcus pneumoniae, commonly known as pneumococcus, can cause severe illness and even death in children. To combat this, pneumococcal conjugate vaccines (PCVs) have been developed and proven effective in reducing pneumococcal disease caused by vaccine serotypes.

A recent phase 3 study published in the journal American Academy Of Pediatrics evaluated the safety and tolerability of VAXNEUVANCE (V114), a 15-valent PCV, in infants. It was found that V114 pneumococcal vaccine safe and well tolerated among healthy infants.

The study conducted by Natalie Banniettis and a team of researchers involved 2,409 infants who were randomly assigned to receive either V114 or Prevnar 13 (PCV13) at ages 2, 4, 6, and 12 to 15 months. The primary objective was to assess the proportion of participants experiencing adverse events (AEs) related to the vaccine. Both solicited and unsolicited injection-site and systemic AEs were recorded for 14 days following each vaccination, and serious AEs were monitored for up to 6 months after the final dose of PCV.

● This study enrolled a total of 2,409 participants who were randomly assigned in a 5:1 ratio to receive either VAXNEUVANCE (V114) or Prevnar 13 (PCV13) in a 3 + 1 dosing regimen. The majority of participants completed the study, with 99.8% receiving the first vaccination.

● Comparable demographic characteristics were observed between the two vaccination groups, including sex, age at enrollment, race, and ethnicity. The reported medical history conditions were also similar, with jaundice and gastroesophageal reflux disease being the most common conditions.

● Regarding safety, both vaccination groups had a similar proportion of participants experiencing adverse events (AEs) after any dose of the pneumococcal conjugate vaccine (PCV). The occurrence of injection-site, systemic, vaccine-related, and serious AEs was generally comparable between the two groups.

● The most frequently reported AEs were those solicited in the trial, and over 86% of participants in both groups experienced one or more solicited AEs after any PCV dose.

● Irritability and somnolence were the most commonly reported solicited AEs.Body temperature measurements collected for seven days after any PCV dose showed no significant differences between the two vaccination groups, with the majority of participants having a maximum body temperature below 38.5°C.

● The occurrence of unsolicited AEs, such as pyrexia, was similar between the V114 and PCV13 groups. Febrile convulsions were rare and not determined to be vaccine-related by the investigator.

● The incidence of serious AEs was comparable between the two vaccination groups, with the majority of serious AEs being infections. In the V114 group, two participants had vaccine-related serious AEs of pyrexia, both of which were considered mild or moderate and resolved within three days.

● Two deaths occurred during the study, one in each treatment group, but neither death was related to the study vaccines according to the investigator's assessment. Importantly, no participants discontinued the study due to AEs.

Based on these findings, it can be concluded that V114 is well tolerated and exhibits a safety profile comparable to that of PCV13 in infants. These results provide strong support for the

routine use of V114 in this population. Pneumococcal vaccines have consistently demonstrated their efficacy in protecting children from pneumococcal disease, and V114 offers an expanded coverage against emerging serotypes while maintaining coverage against the serotypes included in Prevnar 13.

This study adds valuable evidence to the growing body of research on V114, affirming its safety and tolerability in infants. The availability of a 15-valent PCV like V114 is a significant advancement in preventing pneumococcal disease and its associated morbidity and mortality in children. By including additional serotypes, V114 addresses the evolving landscape of pneumococcal strains and strengthens the protective potential of PCVs. The study results provide reassurance to healthcare professionals and parents alike, supporting the adoption of V114 as a standard vaccine for infants to safeguard them against pneumococcal infections.

Reference:

Banniettis, N., Horn, M., Sadarangani, M., Patel, S. M., Greenberg, D., Oberdorfer, P., Klein, N. P., Rupp, R., Dagan, R., Richmond, P., Lumley, J., Zhou, W., Shi, Y., Tamms, G., Feemster, K., Lupinacci, R., Musey, L., Bickham, K., & V114-031 (PNEU-LINK) study group. (2023). Safety and tolerability of V114 pneumococcal vaccine in infants: A phase 3 study. Pediatrics, e2022060428. https://doi.org/10.1542/peds.2022-060428.