A randomized, open-label, phase 3 study evaluating safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in Chinese infants and children under 6 years of age

Figures & data

Figure 1. Participant disposition in (a) Cohort 1 (participants 42–56 days of age at Dose 1), (b) Cohort 2 (participants 7–<12 months of age at Dose 1), (c) Cohort 3 (participants 1–<2 years of age at Dose 1), and (d) Cohort 4 (participants 2–<6 years of age at Dose 1).

AE = adverse event; Hib = Haemophilus influenzae type b; PCV13 = 13-valent pneumococcal conjugate vaccine.

Table 1. Participant demographics.

	Cohort 1	Cohort 2		Cohort 3		Cohort 4
	PCV13 (n^a = 125)	PCV13 (n^a = 236)	Hib Vaccine (n^a = 117)	PCV13 (n^a = 165)	Hib Vaccine (n^a = 83)	PCV13 (n^a = 138)	Hib Vaccine (n^a = 68)
Sex, n^b (%)
Male	66 (52.8)	121 (51.3)	67 (57.3)	82 (49.7)	47 (56.6)	82 (59.4)	31 (45.6)
Female	59 (47.2)	115 (48.7)	50 (42.7)	83 (50.3)	36 (43.4)	56 (40.6)	37 (54.4)
Asian, n^b (%)	125 (100.0)	236 (100.0)	117 (100.0)	165 (100.0)	83 (100.0)	138 (100.0)	68 (100.0)
Age at Dose 1
n^b	125	236	117	165	83	138	68
Mean (SD)	49.1 (3.78) days	286.0 (41.06) days	285.9 (40.40) days	1.5 (0.27) years	1.6 (0.30) years	3.3 (1.11) years	3.3 (1.04) years
Median (range)	49.0 (43–56) days	284.0 (216–361) days	281.0 (217–360) days	1.5 (1.0–2.0) years	1.6 (1.0–2.0) years	3.1 (2.0–6.0) years	3.3 (2.0–5.8) years
Age at Dose 2
n^b	114	219	107	146	N/A	N/A	N/A
Mean (SD)	106.0 (13.88) days	319.5 (42.48) days	319.6 (41.05) days	1.7 (0.27) years	N/A	N/A	N/A
Median (range)	102.0 (86–166) days	318.0 (249–411) days	316.0 (252–390) days	1.7 (1.2–2.1) years	N/A	N/A	N/A
Age at Dose 3
n^b	111	214	N/A	N/A	N/A	N/A	N/A
Mean (SD)	176.4 (20.99) days	409.9 (31.86) days	N/A	N/A	N/A	N/A	N/A
Median (range)	175.0 (142–235) days	408.0 (366–555) days	N/A	N/A	N/A	N/A	N/A

Hib = Haemophilus influenzae type b; N/A = not applicable; PCV13 = 13-valent pneumococcal conjugate vaccine.

^aNumber of participants in the vaccine group unless otherwise noted.

^bNumber of participants in the specified category.

Figure 2. PCV13 serotype-specific IgG GMCs 1 month after the infant series (Cohort 1) or 1 month after the last dose (Cohorts 2, 3, and 4) and GMFRs from baseline to 1 month after the last vaccination.

GMC = geometric mean concentration; GMFR = geometric mean fold rise; Hib = Haemophilus influenzae type b; IgG = immunoglobulin G; PCV13 = 13-valent pneumococcal conjugate vaccine.

Cohort 1 PCV13, n = 71–72; Cohort 2 PCV13, n = 173–176; Cohort 2 Hib vaccine, n = 71–72; Cohort 3 PCV13, n = 126–127; Cohort 3 Hib vaccine, n = 76–77; Cohort 4 PCV13, n = 128–131; Cohort 4 Hib vaccine, n = 64–67.

Figure 3. PCV13 serotype-specific OPA GMTs 1 month after the infant series (Cohort 1) or 1 month after the last dose (Cohorts 2, 3, and 4) and GMFRs from baseline to 1 month after the last vaccination.

GMT = geometric mean titer; GMFR = geometric mean fold rise; Hib = Haemophilus influenzae type b; OPA = opsonophagocytic activity; PCV13 = 13-valent pneumococcal conjugate vaccine.

Cohort 1 PCV13, n = 37; Cohort 2 PCV13, n = 87; Cohort 2 Hib vaccine, n = 34; Cohort 3 PCV13, n = 78; Cohort 3 Hib vaccine, n = 42; Cohort 4 PCV13, n = 71; Cohort 4 Hib vaccine, n = 36.

Figure 4. Percentage of participants with local reactions within 7 days after each dose in (a) Cohort 2, (b) Cohort 3, and (c) Cohort 4.

Hib = Haemophilus influenzae type b; PCV13 = 13-valent pneumococcal conjugate vaccine.

Cohort 2 PCV13, n = 236 for dose 1, n = 219 for dose 2, and n = 194 for dose 3; Cohort 2 Hib vaccine, n = 117 for dose 1, n = 107 for dose 2, and not applicable for dose 3; Cohort 3 PCV13, n = 164 for dose 1, n = 146 for dose 2; Cohort 3 Hib vaccine, n = 83 for dose 1 and not applicable for dose 2; Cohort 4 PCV13, n = 137–138 for dose 1; Cohort 4 Hib vaccine, n = 67 for dose 1. Severity grading is outlined in Table S2.

In the figure legend, change all instances of ”dose” to ”Dose”

Figure 5. Percentage of participants with systemic events within 7 days after each dose in (a) Cohort 2, (b) Cohort 3, and (c) Cohort 4.

Hib = Haemophilus influenzae type b; PCV13 = 13-valent pneumococcal conjugate vaccine. Cohort 2 PCV13, n = 236 for dose 1, n = 219 for dose 2, and 194 for dose 3; Cohort 2 Hib vaccine, n = 117 for dose 1, n = 107 for dose 2, and not applicable for dose 3; Cohort 3 PCV13, n = 164 for dose 1 and n = 146 for dose 2; Cohort 3 Hib vaccine, n = 83 and not applicable for dose 2; Cohort 4 PCV13, n = 137–138; Cohort 4 Hib vaccine, n = 67–68.

Severity grading is outlined in Table S2. Fever grading is shown in the color key.

Table 2. Summary of AEs reported from the signing of informed consent document through 1 month after the infant series (Cohort 1) or 1 month after the last dose (Cohorts 2, 3, and 4)^a.

	Cohort 1	Cohort 2		Cohort 3		Cohort 4
	PCV13 (n^b = 125)	PCV13 (n^b = 236)	Hib Vaccine (n^b = 117)	PCV13 (n^b = 165)	Hib Vaccine (n^b = 83)	PCV13 (n^b = 138)	Hib Vaccine (n^b = 68)
Number of AEs	19	101	34	27	1	12	1
Participants with AEs, n (%)	14 (11.2)	76 (32.2)	29 (24.8)	21 (12.7)	1 (1.2)	11 (8.0)	1 (1.5)
Participants with treatment-related AEs, n (%)	3 (2.4)	6 (2.5)	0	3 (1.8)	0	9 (6.5)	1 (1.5)
Participants with life-threatening AEs, n (%)	0	0	0	0	0	0	0
Participants with SAEs, n (%)^c	4 (3.2)	5 (2.1)	1 (0.9)	2 (1.2)	0	2 (1.4)	1 (1.5)
Participants with severe AEs, n (%)	0	9 (3.8)	7 (6.0)	1 (0.6)	0	0	0
Participants who withdrew owing to AEs, n (%)	0	1 (0.4)	0	0	0	0	0
Participants who permanently discontinued vaccination owing to AEs, n (%)	0	0	0	0	0	0	0
Participants with temporary delay due to AEs, n (%)	0	1 (0.4)	1 (0.9)	1 (0.6)	0	0	0
Participants who died, n (%)	0	0	0	0	0	0	0

AE = adverse event; Hib = Haemophilus influenzae type b; PCV13 = 13-valent pneumococcal conjugate vaccine; SAE=serious adverse event.

^aTime point unless otherwise specified.

^bNumber of participants evaluable for AEs.

^cThrough 6 months after the last dose for Cohorts 2, 3, and 4.