Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial

Figures & data

Figure 1. Flow of the study and subject disposition.

Table 1. Seroconversion: Comparative analysis and non inferiority analysis for subjects with pre-immune titer <10 mIU/mL cohort I and II receiving Bio Pox™ and Varivax™ at all study centers.

Group	Seroconversion N (%)	Post-immune Median (IQR)	P value (between the groups for seroconversion)	P value (between the groups for post-immune titres)
Cohort I
Bio Pox™ (n^* = 26)	20 (77)	15.7 (10–20.7)	0.528	0.713
Varivax™ (n^* = 28)	19 (68)	19 (5–37.7)
Cohort II
Bio Pox™ (n^* = 49)	40 (82)	21.6 (17.7–26.1)	0.897	0.360
Varivax™ (n^* = 47)	39 (83)	21.9 (18.5–33.0)
Combined
Bio Pox™ (n^* = 75)	60 (80)	20.1 (13.9–26.0)	0.692	0.275
Varivax™ (n^* = 75)	58 (77)	21.1 (10–35.9)

IQR: Inter quartile range, p value for cohort I and cohort II (within the groups, pre-immune median and post-immune median): <0.001; p value (between the groups):

* represents number of children having pre-immune anti VZV IgG titers< 10mIU/ml

Table 2. Adverse events (local, systemic and skin reactions) and post-immunization safety profile recorded for combined cohort I (> 6 to 12 years) and cohort II (1 to 6 years) at different time intervals of post vaccination for Bio Pox™ and Varivax™ at all study centers.

Adverse Events	Bio Pox™, N	Varivax™, N	Status	Bio Pox^TM, N/%	Varivax^TM, N/%
30 min
Pain	40	33	Excellent	99/(78.6)	105/(83.3)
Erythema	6	8	Good	24/(19.0)	21/(16.7)
Inflammation /induration (swelling)	15	14	Fair/ Bad	3/(2.4)	0
60 min
Pain	19	7	Excellent	110/(87.3)	117/(92.9)
Erythema	3	4	Good	16/(12.7)	9/(7.1)
Inflammation /induration (swelling)	16	10	Fair/ Bad	0	0
90 min
Pain	4	1	Excellent	120/(95.2)	123/(97.6)
Erythema	2	1	Good	6/(4.8)	3/(2.4)
Inflammation /induration (swelling)	14	6	Fair/ Bad	0	0
120 min
Pain	0	0	Excellent	124/(98.4)	126/(100)
Erythema	0	1	Good	2/(1.6)	0
Inflammation /induration (swelling)	11	5	Fair/ Bad	0	0
>5–42 days
Papules (systemic)	0	1	Excellent	126/(100)	125/(99.2)
			Good	0	0
			Fair/ Bad	0	0