A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States

Figures & data

Table 1. Participant Demographics (Safety Population)

Demographic	Vaccine Group
	PCV20 (n = 35)	cPCV7 (n = 34)	PCV13 (n = 34)	Total (N = 103)
Sex, n (%)
Male	15 (42.9)	13 (38.2)	14 (41.2)	42 (40.8)
Female	20 (57.1)	21 (61.8)	20 (58.8)	61 (59.2)
Race, n (%)
Asian	35 (100.0)	34 (100)	34 (100)	103 (100)
Ethnicity, n (%)
Non-Hispanic/non-Latino	35 (100.0)	34 (100)	34 (100)	103 (100)
Racial designation, n (%)
Japanese	35 (100.0)	34 (100)	34 (100)	103 (100)
Age at vaccination, y
Mean ± SD	29.9 ± 10.29	32.7 ± 10.19	31.4 ± 9.99	31.3 ± 10.12
Median (range)	28.0 (18–47)	33.5 (18–49)	30.5 (18–49)	31.0 (18–49)

cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV20 = 20-valent pneumococcal conjugate vaccine; SD = standard deviation.

Figure 1. Participant Disposition. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV20 = 20-valent pneumococcal conjugate vaccine

Figure 2. Reactogenicity Events Including (a) Local Reactions and (b) Systemic Events Occurring Up to 14 Days After Vaccination. The single report of fever (38.8°C; 1 participant in the PCV20 group) is not included. Number of participants: PCV20, n = 35; cPCV7, n = 34; PCV13, n = 34. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV20 = 20-valent pneumococcal conjugate vaccine

Figure 3. Pneumococcal OPA GMTs and GMFRs With 2-Sided 95% CIs for Each Serotype. Assay results below the LLOQ were set to 0.5 × LLOQ in the analysis. cPCV7 = complementary 7-valent pneumococcal conjugate vaccine; GMFRs = geometric mean fold-rises from before vaccination to 1 month after vaccination; GMTs = geometric mean titers; LLOQ = lower limit of quantitation; OPA = opsonophagocytic activity; PCV13 = 13-valent pneumococcal conjugate vaccine; PCV20 = 20-valent pneumococcal conjugate vaccine