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.