Safety and Immunogenicity of a novel three-dose recombinant nanoparticle rabies G protein vaccine administered as simulated post exposure immunization: A randomized, comparator controlled, multicenter, phase III clinical study

Figures & data

Figure 1. Disposition of the study participants.

Table 1. Demographic characteristics of the study subjects

Parameters	Test vaccine arm (N = 533)		Reference vaccine arm (N = 267)
	Male; N (%)	Female; N (%)	Male; N (%)	Female; N (%)
Number of subjects	440 (82.55%)	93 (17.45%)	225 (84.27%)	42 (15.73%)
Age (years) (Mean ± SD)	33.116 ± 8.310	37.419 ± 12.108	35.347 ± 10.176	39.119 ± 14.049
Height (cm) (Mean ± SD)	164.609 ± 7.018	155.845 ± 12.818	164.715 ± 5.817	154.995 ± 6.030
Weight (kg) (Mean ± SD)	63.413 ± 9.249	56.772 ± 7.080	64.043 ± 8.374	55.643 ± 7.197

Table 2. Adverse drug events among the study subjects

Adverse drug events	Test vaccine (n = 533)	Reference vaccine (n = 267)	P value
Number of subjects with ADEs	53 (9.94%)	46 (17.23%)	0.0032
Local ADEs*
Pain	59 (7.69%)	59 (13.56%)	0.0075
Redness	16 (2.81%)	12 (3.37%)	0.065
Swelling	4 (0.75%)	6 (1.87%)	0.1559
Systemic ADEs*
Fever	2 (0.38%)	4 (1.5%)	0.1931
Headache	2 (0.38%)	2 (0.75%)	0.8607
Ear pain	1 (0.19%)	0 (0%)	0.0826
Urticaria	1 (0.19%)	0 (0%)	0.0826
Joint pain	0 (0%)	1 (0.19%)	0.0826
Nausea	0 (0%)	1 (0.19%)	0.0826

*Multiple response.

Table 3. Sero-response of the study subjects

Day	Test vaccine (n = 533)	Reference vaccine (n = 267)	P value
Sero-response %
Day 0	0	0
Day 14	99.24	97.72	P = .718
Day 42	98.69	100