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Updated: Jul 26, 2025
Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study
Natalie Banniettis1, Michael Horn2, Manish Sadarangani3
1Merck & Co., Inc., Rahway, New Jersey.
Insights
VAXNEUVANCE (V114), a new pneumococcal conjugate vaccine (PCV), demonstrated a safety profile comparable to Prevnar 13 (PCV13) in infants. This study supports the routine use of V114 for preventing pneumococcal disease.
Area of Science:
- Pediatric Infectious Diseases
- Vaccinology
- Clinical Trials
Background:
- Streptococcus pneumoniae causes significant childhood illness and death.
- Pneumococcal conjugate vaccines (PCVs) effectively reduce disease incidence.
- VAXNEUVANCE (V114) is a 15-valent PCV including serotypes from PCV13 plus 22F and 33F.
Purpose of the Study:
- To evaluate the safety and tolerability of VAXNEUVANCE (V114) in infants.
- To compare the safety profile of V114 against the existing PCV13 vaccine.
Main Methods:
- A large Phase 3 clinical trial randomized 2409 infants.
- Participants received V114 or PCV13 at 2, 4, 6, and 12-15 months of age.
- Adverse events (AEs) were monitored for up to 6 months post-vaccination.
Main Results:
- V114 exhibited comparable safety and tolerability to PCV13.
- Most adverse events were mild-to-moderate, short-lived, and similar between groups.
- No participants discontinued the study due to adverse events.
Conclusions:
- VAXNEUVANCE (V114) is well-tolerated in infants.
- The safety profile of V114 is comparable to PCV13.
- Results support the routine use of V114 for infant immunization.
Background And Objectives:
Disease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in children. Pneumococcal conjugate vaccines (PCVs) are well tolerated and effective at reducing pneumococcal disease caused by vaccine serotypes. VAXNEUVANCE (V114) is a 15-valent PCV containing 13 serotypes in Prevnar 13 (PCV13), plus serotypes 22F and 33F. This large phase 3 study evaluated safety and tolerability of V114 in infants.
Methods:
In total, 2409 infants were randomized to receive V114 or PCV13 at 2, 4, 6, and 12 to 15 months of age. Safety was evaluated as the proportion of participants with adverse events (AEs). Solicited and unsolicited injection-site and systemic AEs were collected for 14 days after each study vaccination, and serious AEs up to 6 months after the last PCV dose.
Results:
The proportions of participants with injection-site, systemic, vaccine-related, and serious AEs were generally comparable between recipients of V114 and PCV13. The most frequently reported AEs were solicited, with irritability and somnolence being the most frequent in both groups. Although the incidence of some AEs was higher in the V114 group, the between-group differences were small. The majority of experienced AEs were of mild-to-moderate intensity and lasted ≤3 days. There were 2 vaccine-related serious AEs of pyrexia in the V114 group, and 2 nonvaccine-related deaths, 1 in each group. No participant discontinued study vaccine because of AEs.
Conclusions:
V114 is well tolerated and has a generally comparable safety profile to that of PCV13. These study results support routine use of V114 in infants.
