Safety and immunogenicity of single dose live attenuated varicella vaccine (VR 795 Oka strain) in healthy Indian children: A randomized controlled study

Figures & data

Table 1. Baseline Demographic and Laboratory Parameters of the Enrolled Subjects

Parameters	Total (N = 268 )	Test (N = 134)	Control (N = 134)	P value
Female	110	57	53	0.619
Age (months)*	46.3 ± 30.3	44.5 ± 29.6	48.13 ± 31.1	0.331
12–17	35 (13%)	21 (16%)	14 (10%)	0.282
18–59	160 (60%)	81 (60%)	79(59%)	0.282
60 and over	73 (27%)	32 (24%)	41(31%)	0.282
Weight (Kg)*	14.1 ± 6.5	14.21 ± 7.75	14.1 ± 5.0	0.834
Temperature (°C)	36.7	36.7	36.7	0.519
Pulse Rate (per minute)**	85.7 ± 8.1	85.66 ± 8.12	85.7 ± 8.2	0.946
Hemoglobin (g/dl)*	11.2 ± 1.2	11.2 ± 1.1	11.2 ± 1.3	0.819
TLC (mm^3)*	10,762.3 ± 3,466.5	11,062.0 ± 3,627.3	10,462.7 ± 3,284.0	0.157
Neutrophils (%) *	42.1 ± 13.0	42.6 ± 13.9	41.61 ± 12.0	0.554
Lymphocytes (%) *	45.1 ± 12.7	44.4 ± 13.1	45.8 ± 12.3	0.410
Eosinophils (%) *	5.4 ± 4.7	5.46 ± 5.1	5.39 ± 4.3	0.902
Basophils (%) *	0.4 ± 0.5	0.39 ± 0.3	0.44 ± 0.6	0.359
Monocytes (%) *	6.4 ± 3.1	6.44 ± 2.8	6.32 ± 3.3	0.760
Platelet Count (lakhs/mm^3) *	3.2 ± 1 .2	3.3 ± 1 .0	3.2 ± 1.4	0.403

*Mean ± Standard deviation

Figure 1. Subject Disposition.

Figure 2. Seroconversion Rate based on Extent of Rise of Varicella (VZV) IgG Antibody from Baseline values to 6 weeks Post Vaccination (N-total no. of evaluated subjects, n-no. of seroconverted subjects).

Table 2. GMT of Anti VZV IgG Antibody in Control and Test Group

	Test		Control
Category	N	GMT mIU/mL (95%CI)	N	GMT mIU/mL (95%CI)	p-value
Pre-vaccination	128	13.1 (12.2–14.1)	128	12.6 (11.6–13.6)	<0.001*
12–17 months	21	12 (10.7–13.4)	14	11.3 (10.3–12.4)	0.007*
18–59 months	99	12.6 (11.7–13.6)	89	12.2 (11.3–13.3)	0.001*
>60 months	29	14.9 (12.4–17.9)	39	13.32 (11.2–15.8)	0.066
Post vaccination	128	112.5 (98.3–128.7)	128	67.8 (57.4–80.0)	<0.001*
12–17 months	21	133.3 (93.0–191.1)	14	52.9 (32.0–87.3)	0.007*
12–59 months	99	111.0 (94.9–129.8)	89	64.5 (52.7–79.1)	0.001*
>60 months	29	117.8 (88.50–156.6)	39	75.6 (56.2–101.8)	0.066

*p-value is significant

Table 3. Percentage and Duration of Local AE and Systemic AE within 48 hr Post Vaccination

	Percentage, N (%)			Duration (days) Mean, (min/max)
Local AE	Test (N = 134 )	Control (N = 134 )	p-value	Test (N = 143 )	Control (N = 134 )	p-value
Pain	38 (28.4%)	30 (22.4%)	0.260	1 (1,7)	1 (1,3)	0.809
Swelling	12 (9%)	5 (3.7%)	0.078	1 (1,7)	1 (1,1)	1.000
Redness	5 (3.7%)	1 (0.8%)	0.097	1 (1,7)	1 (1,1)	0.799
Bluish discoloration	0	1 (0.8%)	0.315	0	1 (0.1)	NA
Systemic AE
Cough	1 (0.7%)	1 (0.7%)	1.0	1(0,1)	1 (1,5)	0.667
Fever	0	2 (1.5%)	0.154	0	1 (1,3)	NA
Excessive crying	1 (0.75%)	1 (0.75%)	1.000	2 (0,2)	2 (0,2)	1.000

*AE after 48 hr of post vaccination, N-number of subjects, T-no. of local AE in test, c-number of AE in control

Table 4. Percentage and Duration of Local and Systemic AE after 48 hr Post Vaccination

	Test (N = 134) N (%)		Control (N = 134) N (%)
Adverse event	N (%)	Duration (Days)	N (%)	Duration (days)
Local AE
Pain Redness	2 (1.49%) 0	1 -	2 (1.5%) 1 (0.8%)	1 1
Systemic AE
Cough	9 (6.7)	3	7 (5.2)	7
Cough and cold	2 (1.5)	4	1 (0.8)	5
Diarrhea	3 (2.24)	4	6 (4.5)	4
Fever	9 (6.7)	0	8 (6.0)	3
LRTI and Fever	1 (0.8)	6	1 (0.8)	4
Otitis externa and fever	1 (0.8)	3	0	0
Maculopapular rash	2 (1.5)	3	1 (0.8)	1
Lymphadenitis	1 (0.8)	8	0	0
Tiredness	1 (0.8)	1	0	1
Generalisedmuscleache	1 (0.8)	3	0	0
Excessive crying	0	0	2 (1.5)	2.5
Scabies	1 (0.8)	2	0	0
Vertigo	1 (0.8)	3	0	0
Vomiting	4 (3.0)	3	2 (1.5)	3
Worm Infection	1 (0.8)	3	0	0
Allergy	0	0	1 (0.8)	6
Vomiting and Headache	0	0	1 (0.8)	1
Insect bite allergy	0	0	1 (0.8)	3

N-total no. of subjects, LRTI: Lower Respiratory Tract Infection in Children