Safety of the 15-valent pneumococcal conjugate vaccine: A phase I clinical trial

Figures & data

Figure 1. Trial Profile.

Table 1. Summary of demographic characteristics.

	≥18 years (N=20)	1-5 years (N=20)	3 months (N=20)	2 months (N=20)	Total (N=80)
Age Mean (SD)	40.72 (10.84)	3.75 (1.12)	3.35 (0.22)	2.02 (0.43)	9.15 (16.62)
Sex (male/female)	8/12	11/9	11/9	9/11	49/51
Ethnicity (Han/other)	20/0	17/3	20/0	20/0	94/6
Height (cm) Mean (SD)	164.8 (8.8)	102.2 (10.2)	64.1 (2.0)	61.5 (1.7)	93.6 (39.1)
Weight (kg) Mean (SD)	76.28 (11.16)	16.28 (4.27)	6.81 (0.88)	5.23 (0.86)	22.83 (27.64)
Body temperature (℃) Mean (SD)	36.34 (0.30)	36.50 (0.20)	36.58 (0.23)	36.76 (0.21)	36.55 (0.26)

Table 2. Summary of adverse events (AEs) in the adult, toddler, and infant cohorts.

	≥18 years (N=20)		1-5 years (N=20)		3 months (N=20)		2 months (N=20)
	n	%	n	%	n	%	n	%
AEs	14	70.00	12	60.00	16	80.00	17	85.00
solicited AEs	13	65.00	10	50.00	12	60.00	14	70.00
unsolicited AEs	4	20.00	5	25.00	12	60.00	14	70.00
vaccination-related	14	70.00	10	50.00	12	60.00	14	70.00
vaccination-irrelevant AE	1	5.00	5	25.00	12	60.00	14	70.00

Table 3. Summary of vaccination-related adverse events (AEs) in the adult and toddler cohorts.

	≥18 years (N=20)		1-5 years (N=20)			Total (N=40)
	n	%		n	%	N	%
Solicited AE	13	65.00		10	50.00	23	57.50
systemic reaction	6	30.00		5	25.00	11	27.50
fever	5	25.00		5	25.00	10	25.00
myalgia	1	5.00		0	0.00	1	2.50
local reaction	9	45.00		9	45.00	18	45.00
pain	9	45.00		3	15.00	12	30.00
pruritus	0	0.00		3	15.00	3	7.50
redness	0	0.00		5	25.00	5	12.50
swelling	2	10.00		7	35.00	9	22.50
induration	1	5.00		2	10.00	3	7.50
Unsolicited AE	3	15.00		0	0.00	3	7.50
Increased white blood cell count	1	5.00		0	0.00	1	2.50
Urinary protein positive	1	5.00		0	0.00	1	2.50
urinary erythrocytes positive	1	5.00		0	0.00	1	2.50

Table 4. Summary of vaccination-related adverse events (AEs) in the infant cohort.

	3 months			2 months			Total
	N	n	%	N	n	%	N	n	%
systemic reaction	20	12	60.00	20	14	70.00	40	26	65.00
fever	20	11	55.00	20	12	60.00	40	23	57.50
Post1 Dose	20	10	50.00	20	7	35.00	40	17	42.50
Post2Dose	19	7	36.84	19	3	15.79	38	10	26.32
Post3 Dose	19	5	26.32	18	7	38.89	37	12	32.43
anorexia	20	1	5.00	20	0	0.00	40	1	2.50
Post1 Dose	20	1	5.00	20	0	0.00	40	1	2.50
Post2Dose	19	0	0.00	19	0	0.00	38	0	0.00
Post3 Dose	19	0	0.00	18	0	0.00	37	0	0.00
nausea	20	1	5.00	20	0	0.00	40	1	2.50
Post1 Dose	20	1	5.00	20	0	0.00	40	1	2.50
Post2 Dose	19	0	0.00	19	0	0.00	38	0	0.00
Post3 Dose	19	0	0.00	18	0	0.00	37	0	0.00
diarrhoea	20	3	15.00	20	3	15.00	40	6	15.00
Post1 Dose	20	2	10.00	20	1	5.00	40	3	7.50
Post2Dose	19	1	5.26	19	1	5.26	38	2	5.26
Post3 Dose	19	0	0.00	18	2	11.11	37	2	5.41
Irritability/abnormal crying	20	1	5.00	20	1	5.00	40	2	5.00
Post1 Dose	20	1	5.00	20	1	5.00	40	2	5.00
Post2 Dose	19	0	0.00	19	1	5.26	38	1	2.63
Post3 Dose	19	0	0.00	18	0	0.00	37	0	0.00
Allergy	20	0	0.00	20	1	5.00	40	1	2.50
Post1 Dose	20	0	0.00	20	0	0.00	40	0	0.00
Post2 Dose	19	0	0.00	19	1	5.26	38	1	2.63
Post3Dose	19	0	0.00	18	0	0.00	37	0	0.00

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.