PCV15, a pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in infants and children

Figures & data

Table 1. PCV15 pediatric Phase 3 studies.

Study name	Short description	NCT #	Pubmed ID
V114–023 (PNEU-SICKLE)	PCV15 in children with sickle cell disease	NCT03731182	36383730
V114–024 (PNEU-PLAN)	Catch-up vaccination with PCV15	NCT03885934	36150974
V114–025 (PNEU-PED-EU1)	PCV15 2 + 1 regimen pivotal trial	NCT04031846	37105892
V114–026 (PNEU-PED-EU2)	PCV15 2 + 1 regimen pivotal trial – Nordic	NCT04016714	36841723
V114–027 (PNEU-DIRECTION)	Interchangeabilty of PCV15 and PCV13	NCT03620162	36522265
V114–029 (PNEU-PED)	PCV15 3 + 1 regimen pivotal trial	NCT03893448	36621410
V114–030 (PNEU-WAY PED)	PCV15 in children living with HIV	NCT03921424	36939067
V114–031 (PNEU-LINK)	Safety and tolerability of PCV15	NCT03692871	37309607
V114–032 (PNEU-ERA)	Effectiveness of PCV15 on acute otitis media	NCT04193215	Ongoing
V114–033	Subcutaneous 3 + 1 PCV15 regimen (Japan)	NCT04384107	37344262

Figure 1. Safety profile of V114 in healthy infants after any study vaccine dose across 4 studies (V114–025, −027, −029, and − 031). For V114–027, groups 1 (complete PCV13 regimen) and 5 (complete V114 regimen) were used for this analysis. Top: the number (n) and proportion (%) of participants included in each safety category. Bottom: solicited AE summary, with proportions of participants experiencing an AE and intensity in the stacked bar in the V114 (P15) and PCV13 (P13) groups. The 2 deaths that occurred in recipients of V114 were due to complications from congenital heart disease and a craniocerebral injury following a motor vehicle accident.

Table 2. Summary of concomitant vaccine immunogenicity assessments from PCV15 studies using 3 + 1 and 2 + 1 vaccination regimens.

		2 + 1 schedule	2 + 1 alternative schedule	3 + 1 schedule
Antigen	Criteria	Percent difference PCV15-PCV13 (95% CI)			Noninferiority margin - %
Diphtheria toxoid	% ≥0.1 IU/ml	−0.6 (−1.7, 0.4)	0.2 (−0.6, 1.0)	−0.7 (−2.6, 1.1)	−10
Tetanus toxoid	% ≥0.1 IU/ml	−0.4 (−1.3, 0.3)	0.2 (−0.6, 1.0)	0.2 (−0.4, 0.8)	−5
Pertussis-PT	% ≥5 EU/ml	−0.2 (−1.3, 0.9)	0.2 (−0.6, 1.0)	0.5 (−0.7, 1.9)	−10
Pertussis-FHA	% ≥5 EU/ml	−0.2 (−1.0, 0.5)	0.2 (−0.6, 1.0)	−0.3 (−1.3, 0.8)	−10
Pertussis-FIM 2/3	% ≥20 EU/ml		0.2 (−0.8, 1.2)	2.0 (−3.1, 7.1)	−10
Pertussis-PRN	% ≥5 EU/ml	−0.4 (−1.3, 0.3)	0.2 (−0.8, 1.2)	1.8 (−3.2, 6.8)	−10
Poliovirus 1	% with NAb ≥ 1:8 dilution	0.0 (−0.7, 0.7)	0.0 (−0.9, 0.9)	0.0 (−0.7, 0.8)	−5
Poliovirus 2	% with NAb ≥ 1:8 dilution	0.0 (−0.7, 0.7)	0.2 (−0.6, 1.1)	0.0 (−0.6, 0.6)	−5
Poliovirus 3	% with NAb ≥ 1:8 dilution	0.2 (−0.5, 1.1)	0.0 (−0.8, 0.7)	0.0 (−0.6, 0.6)	−5
Hib-PRP	% ≥0.15 ug/ml	0.4 (−1.3, 2.1)	−1.1 (−3.3, 0.9)	−1.4 (−4.3, 1.5)	−10
HBsAg	% ≥10 mIU/ml	−0.8 (−2.0, 0.0)	−0.6 (−2.0, 0.5)	−0.2 (−3.7, 2.0)	−10
Hepatitis A	% ≥10 mIU/ml			0.3 (−1.6, 2.2)	−10
Measles	% ≥225 mIU/ml			−0.2 (−1.8, 1.3)	−5
Mumps	% ≥10 mumps Ab units/ml			−1.7 (−3.8, 0.2)	−5
Rubella	% ≥10 IU/ml			−0.9 (−2.3, 0.5)	−5
Varicella zoster	% ≥5 gpELISA units/ml			−1.3 (−3.2, 0.5)	−10
				Ratio PCV15/PCV13 (95% CI)
Rotavirus	IgA GMT			0.97 (0.70, 1.34)	>0.5

CI=confidence interval; IU=international unit; EU=endotoxin unit; PT=pertussis toxin; FHA=filamentous hemagglutinin; FIM 2/3=fimbriae types 2 and 3; PRN=pertactin; Nab=neutralizing antibodies; Hib=Haemophilus influenzae type b; PRP=polyribosylribitol phosphate; HBsAg=hepatitis B surface antigen; Ab=antibody; gpELISA=glycoprotein enzyme-linked immunosorbent assay; IgA=immunoglobulin A; GMT=geometric mean titer.