A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16–24 months

Figures & data

Table 1. Post vaccination incidence of solicited adverse events.

Adverse event	(Overall N=24)
	e	n	%	95% CI
Injection site pain
Any	17	17	70.83	[48.91,87.38]
Grade 3	2	2	8.3	[1.03,27.00]
Injection site erythema
Any	4	4	16.7	[4.74,37.38]
Grade 3	0	0	0.0	NE
Injection site swelling
Any	6	6	25	[9.77,46.71]
Grade 3	0	0	0.0	NE
Fever
Any	14	14	58.3	[36.64,77.89]
Grade 3	0	0	0.0	NE
Irritability
Any	18	18	75.0	[53.29,90.23]
Grade 3	0	0	0.0	NE
Abnormal Crying
Any	2	2	8.3	[1.03,27.00]
Grade 3	0	0	0.0	NE
Decreased appetite
Any	5	5	20.8	[7.13,42.15]
Grade 3	1	1	4.2	[0.11,21.12]
Drowsiness
Any	1	1	4.2	[0.11,21.12]
Grade 3	0	0	0.0	NE

e =Number of events, n =Number of subjects with adverse events, NE =Non Estimable, % = Percentages of subjects, CI= Confidence interval.

Table 2. Seroprotection rate & GMC at baseline and 1-month post vaccination.

Antibody	Pre vaccination (N=24)	Post vaccination (N=24)
Anti Diphtheria (IU/ml)
GMC	0.02 [0.01, 0.03]	1.59 [1.06,2.37]
≥0.1	5 (20.8%) [7.13,42.15]	24 (100.0%) [85.75,100.00]
Anti Tetanus (IU/ml)
GMC	0.56 [0.33,0.94]	15.83 [11.52,21.74]
≥0.1	21 (87.5%) [67.64,97.34]	24 (100.0%) [85.75,100.00]
Anti Pertussis (U/ml)
GMC	5.97 [4.16,8.57]	48.66 [33.80,70.05]
>24 U/ml	1 (4.2%) [0.11,21.12]	18 (75.0%) [53.29,90.23]
Anti Hepatitis B (mIU/ml)
GMC	139.71[81.78,238.67]	7338.87 [5675.31,9490.06]
≥10	24 (100.0%) [85.75,100.00]	24 (100.0%) [85.75,100.00]
Anti PRP (µg/ml)
GMC	2.82 [1.68,4.75]	37.13 [33.40,41.26]
≥0.15	23 (95.8%) [78.88,99.89]	24 (100.0%) [85.75,100.00]
≥1	20 (83.3%) [62.62,95.26]	24 (100.0%) [85.75,100.00]
Anti Polio Virus type1 (1/dilution)
GMC	120.82 [112.82,129.38]	128.00 [128.00,128.00]
≥8	24 (100.0%) [85.75,100.00]	24 (100.0%) [85.75,100.00]
Anti Polio Virus type3 (1/dilution)
GMC	30.20 [19.68,46.36]	124.36 [118.35,130.67]
≥8	21 (87.5%) [67.64,97.34]	24 (100.0%) [85.75,100.00]