Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects

Figures & data

Table 1. Demographics (All subjects as treated population).

	PPV23
	(N = 102)
	n	(%)
Gender
Male	65	(63.7)
Female	37	(36.3)
Age (years)
2 to 6	12	(11.8)
7 to 13	9	(8.8)
14 to 17	4	(3.9)
18 to 49	27	(26.5)
≥50	50	(49.0)
Mean (SD)	40.4 (23.1)
Median	49
Range	2 to 79
Race
White	101	(99.0)
Other	1	(1.0)

N = Number of subjects randomized in the vaccination group.

n = Number of subjects in each category.

Table 2. Serotype-specific IgG GMCs at prevaccination and 28 d postvaccination.

Serotype	Timing to Vaccination	IgG GMC	95% CI^†
Group 1 (≥50 y of age; N = 48)
1	Prevaccination	0.2	(0.2, 0.3)
	Postvaccination	2.5	(1.7, 3.8)
6B	Prevaccination	0.6	(0.5, 0.8)
	Postvaccination	5.3	(3.4, 8.5)
14	Prevaccination	3.6	(2.5, 5.1)
	Postvaccination	32.7	(22.7, 47.3)
19F	Prevaccination	1.5	(1.1, 2.1)
	Postvaccination	9.9	(7.0, 14.1)
23F	Prevaccination	1.1	(0.7, 1.5)
	Postvaccination	8.1	(5.3, 12.4)
Group 2 (2 to 49 y of age; N = 52)
1	Prevaccination	0.2	(0.2, 0.3)
	Postvaccination	4.1	(3.0, 5.4)
6B	Prevaccination	0.5	(0.4, 0.8)
	Postvaccination	2.7	(1.8, 3.9)
14	Prevaccination	1.3	(0.8, 2.0)
	Postvaccination	13.2	(8.7, 20.1)
19F	Prevaccination	1.5	(1.1, 2.2)
	Postvaccination	12.6	(9.0, 17.8)
23F	Prevaccination	0.6	(0.4, 1.0)
	Postvaccination	5.3	(3.6, 7.7)

^† Based on the natural-log transformed serotype-specific antibody concentrations and back transformed values, and the t-distribution.

N = number of subjects with measurement.

CI = confidence interval

Table 3. Proportion of Subjects with ≥2 -fold Increase in IgG Antibody Concentration for Serotypes 1, 6B, 14, 19F, and 23F (Per-Protocol Immunogenicity Population).

	PPV23 (N = 100)
	Proportion of Subjects with ≥2-Fold Increase
Serotype	n	%	95% CI^†;
Group 1 (≥50 years; N = 48)
1	42	87.5	(74.8, 98.3)
6B	43	89.6	(77.3, 96.5)
14	43	89.6	(77.3, 96.5)
19F	38	79.2	(65.0, 89.5)
23F	42	87.5	(74.8, 95.3)
Group 2 (2 to 49 years; N = 52)
1	50	96.2	(86.8, 99.5)
6B	40	76.9	(63.2, 87.5)
14	46	88.5	(76.6, 95.6)
19F	43	82.7	(69.7, 91.8)
23F	42	80.8	(67.5, 90.4)

^† Based on the 2-sided exact CI method for a single binomial proportion.

^‡ N = Total number of subjects with evaluable serology at Prevaccination and Postvaccination.

^§ n = Total number of subjects with IgG ≥2-fold increase.

CI = confidence interval

Table 4. Summary of Subjects with Adverse Experiences Following Vaccination.

	n	(%)	95% CI
Subjects with follow-up	102
With one or more AE	25	(24.5)	(16.5, 34.0)
Injection-site AEs^†	15	(14.7)	(8.5, 23.1)
Systemic AEs	19	(18.6)	(11.6, 27.6)
With vaccine-related AEs^†	21	(20.6)	(13.2, 29.7)
Injection-site AEs	14	(13.7)	(7.7, 22.0)
Erythema	13	(12.7)
Pain	1	(1.0)
Swelling	1	(1.0)
Systemic AEs	12	(11.8)	(6.2, 19.7)
With serious AEs	0	0.0	(0.0, 3.5)
Serious vaccine-related AEs	0	0.0	(0.0, 3.5)
Who died	0	0.0	(0.0, 3.5)
Discontinued due to AE	0	0.0	(0.0, 3.5)
Discontinued due to vaccine-related AE	0	0.0	(0.0, 3.5)

AE = Adverse experience

n = Number of subjects in each category

^† Determined by the investigator to be possibly, probably, or definitely related to the vaccine

The same subject may appear in different categories, but counted only once in each category