A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age

Figures & data

Figure 1. Stage 2 subject disposition. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; PPSV23 = 23-valent pneumococcal polysaccharide vaccine

Figure 2. Reactogenicity events including (A) local reactions and (B) systemic events occurring within 14 days after vaccination (Stage 2). Three reports of fever (1 and 2 participants in cPCV7 and PPSV23 groups, respectively) are not shown. Number of participants: cPCV7, n = 221; PPSV23, n = 223. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; PPSV23 = 23-valent pneumococcal polysaccharide vaccine

Table 1. Summary of AEs (Stage 2 Safety Population)

	cPCV7 (N=221)		PPSV23 (N=223)
Adverse Event	n (%)	(95% CI)	n (%)	(95% CI)
Through 1 month after vaccination
Any AE	22 (10.0)	(6.3, 14.7)	30 (13.5)	(9.3, 18.6)
Severe AE	2 (0.9)	(0.1, 3.2)	1 (0.4)	(0.0, 2.5)
SAE	0	(0.0, 1.7)	1 (0.4)	(0.0, 2.5)
NDCMC	0	(0.0, 1.7)	4 (1.8)	(0.5, 4.5)
From 1 to 6 months after vaccination
SAE	5 (2.3)	(0.7, 5.2)	5 (2.2)	(0.7, 5.2)
NDCMC	7 (3.2)	(1.3, 6.4)	7 (3.1)	(1.3, 6.4)
From 6 to 12 months after vaccination
SAE	5 (2.3)	(0.7, 5.2)	3 (1.3)	(0.3, 3.9)
NDCMC	9 (4.1)	(1.9, 7.6)	4 (1.8)	(0.5, 4.5)
Throughout the study
SAE	9 (4.1)	(1.9, 7.6)	8 (3.6)	(1.6, 6.9)
NDCMC	15 (6.8)	(3.8, 10.9)	14 (6.3)	(3.5, 10.3)

AE=adverse event; cPCV7=complementary 7-valent pneumococcal conjugate vaccine; NDCMC=newly diagnosed chronic medical condition; PPSV23=23-valent pneumococcal polysaccharide vaccine; SAE=serious adverse event.

Figure 3. Pneumococcal OPA GMTs before and 1 month after vaccination and GMFRs 1 month after vaccination for the cPCV7 serotypes (Stage 2). The LLOQs for each serotype were as follows: 8, 16; 10A, 14; 11A, 32; 12F, 51; 15B, 36; 22F, 28; 33F, 49. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; GMTs = geometric mean titers; GMFRs = geometric mean fold-rises; LLOQ = lower limit of quantitation; OPA = opsonophagocytic activity; PPSV23 = 23-valent pneumococcal polysaccharide vaccine

Figure 4. Pneumococcal OPA GMT antibody response curves and OPA GMFRs for the cPCV7 serotypes from baseline to 12 months after vaccination (Stage 2). Note that the y-axis scales for each graph differ. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; GMT = geometric mean titer; OPA = opsonophagocytic activity; PPSV23 = 23-valent pneumococcal polysaccharide vaccine