Safety and Tolerability of VAXNEUVANCE (V114) in Infants

Streptococcus pneumoniae, commonly known as pneumococcus, is a bacterium that poses a significant threat to the health and well-being of children, leading to substantial morbidity and mortality. Pneumococcal conjugate vaccines (PCVs) have proven to be effective in reducing pneumococcal diseases caused by vaccine serotypes. 

The present study assessed the safety and tolerability of V114, a 15-valent PCV that combines the 15 serotypes, against PCV13.

The study enrolled 2409 infants and randomized them to receive either V114 or PCV13 at the scheduled age. 

The study found-

• Similar proportions of participants with injection-site, systemic, vaccine-related, and serious Adverse Events(AEs) between recipients of V114 and PCV13. 

• The most frequently reported AEs were irritability and somnolence in both groups. 

• Despite some AEs being higher in the V114 group, the between-group differences were small. 

• Most AEs were described as with mild-to-moderate intensity and prevailed ≤3 Days. 

• Two vaccine-related severe pyrexia AEs occurred in the V114 group, and two nonvaccine-related deaths, 1 in each group. 

• Patient compliance was 100% in both groups.

This study proves V114, a new 15-valent pneumococcal conjugate vaccine, is well tolerated in infants and has a safety profile similar to PCV13. These findings support the regular use of V114 in infants for protection against pneumococcal disease.

Banniettis N, et al. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics July 2023; 152 (1): e2022060428. 10.1542/peds.2022-060428