Immunogenicity and reactogenicity of two diphtheria-tetanus-whole cell pertussis vaccines in Iranian pre-school children, a randomized controlled trial

Figures & data

Figure 1. CONSORT (Consolidated Standards of Reporting Trials) participant flow diagram.

Table 1. Demographic characteristics of the children vaccinated with either DTwP-Local or DTwP-Pasteur vaccine

Characteristics	DTwP-Local	DTwP-Pasteur	P-value
Number of subjects	337	335	NA
Gender^a (female/male)	193/144	176/159	0.22
Weight^b (Kg)	20.57 ± 3.43	20.56 ± 3.39	0.79
Birth weight^b (Kg)	3.17 ± 0.46	3.18 ± 0.47	0.99

^aChi-Square test; ^b t-test; NA: Not applicable

Table 2. Comparison of seroprotection rate and geometric mean titer between children immunized with either DTwP-Local or DTwP-Pasteur vaccines

Antibody response	Samples	Seroprotection rate		GMT (CI 95%)			post vs. pre
		DTwP-Local n(%)	DTwP-Pasteur n(%)	DTwP-Local	DTwP-Pasteur	p-value^1	Mean ± SD^2		p-value
							DTwP-Local	DTwP-Pasteur
Diphtheria (IU/ml)	Pre-booster	227(92.2)	281(83.9)	0.25(0.22–0.29)	0.25(0.21–0.29)	0.76	11.68 ± 8	10.77 ± 7.3	0.122
	Post-booster	335(99.4)	335(100)	7.76(7.03–8.58)	8.24(7.63–8.90)	0.36
Tetanus (IU/ml)	Pre-booster	234(69.4)	248(74)	0.29(0.25–0.33)	0.30(0.26–0.34)	0.74	9.56 ± 5.17	9.47 ± 5.48	0.833
	Post-booster	337(100)	335(100)	9.37(8.58–10.24)	8.66(7.92–9.48)	0.22
Pertussis (EU/ml)	Pre-booster	85(25.2)	104(31)	8.41(7.26–9.75)	9.59(8.12–11.31)	0.25	53.63 ± 28.24	72.41 ± 55.66	< 0.001
	Post-booster	237(70.3)	287(85.7)	30.20(27.01–33.77)	47.96(42.99–53.51)	< 0.001

¹ t-test of GMTs;² Mean (standard deviation) antibody titer differences between pre- and post-booster samples

Figure 2. Box plot presentation of serum antibody titers against diphtheria, tetanus and pertussis in Iranian pre-school children. The box length is the interquartile range. Bars show the range from 10th to 90th percentiles. (▬), median

Table 3. Frequency of local and systemic reactions reported during the first week of administration of DTwP vaccines in Iranian pre-school children

	DTwP-Local (n = 337)				DTwP-Pasteur (n = 335)				p-value
	1st day	3rd day	5th day	7th day	1st day	3rd day	5th day	7th day
Local reactions
Pain
Any	86.9	56.4	21.1	10.4	77.9	48.4	18.8	13.7	< 0.001^a
Grade 3	17.8	4.2	0.3	0	10.7	2.1	0	0
Redness
Any	39.8	35.9	8.3	2.7	31.9	25.7	7.2	2.4	< 0.001^a
Grade 3	6.8	13.6	1.8	0.6	3.3	9.9	1.2	0.3
Swelling
Any	38.6	26.7	3.3	1.2	25.4	18.5	4.8	2.4	< 0.001^a
Grade 3	6.5	6.5	0.9	0	2.4	3.9	0.6	0.3
Systemic reactions
Auxiliary temperature
Any	41.5	5.9	0.3	0.3	23	5.1	1.2	0.6	< 0.001^a
Grade 3	3.6	0.3	0	0	0.6	0.3	0	0
Loss of appetite	24	11.9	3	1.5	16.1	6.9	1.5	0.6	< 0.001^b
Gastrointestinal problem	5.9	3.6	0.6	0.6	4.5	3.3	0.3	0	< 0.001^b
Vomiting	8	0.9	0.6	0	5.4	0	0	0	< 0.001^b
Eczema	2.7	4.2	1.2	0.6	2.1	1.5	0.3	0.3	< 0.05^b

The results represent percent of cases with or without the specified complications. Pain: Grade 3, crying when limb was moved/spontaneously painful; Tenderness/swelling: Grade 3, > 20 mm. Fever: Grade 3, ≥ 39°C; ^aFriedman test; ^bCochran test.

Figure 3. Comparison of reactogenicity of DTwP vaccines in Iranian pre-school children during the first week of vaccination.

Pichichero ME, Green JL, Francis AB, Marsocci SM, Lynd AM, Litteer T. Comparison of a three-component acellular pertussis vaccine with whole cell pertussis vaccine in two-month-old children. Pediatr Infect Dis J 1994; 13:193 - 6; http://dx.doi.org/10.1097/00006454-199403000-00005; PMID: 8177626

 PubMed Web of Science ®Google Scholar

Rieber N, Graf A, Hartl D, Urschel S, Belohradsky BH, Liese J. Acellular pertussis booster in adolescents induces Th1 and memory CD8+ T cell immune response. PLoS One 2011; 6:e17271; http://dx.doi.org/10.1371/journal.pone.0017271; PMID: 21408149

 PubMed Web of Science ®Google Scholar