Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: School based cluster randomized study

Figures & data

Table 1. The demographic and lifestyle detail of test and control group.

	Vaccinated Group	Unvaccinated Group
Category	Test Group (N = 905)	Sub Group (N = 102)	Control Group (N = 860)
Sex(M:F)	524:381/(1.37:1)	61:41/(1.49:1)	427:433/(0.98:1)^*
Age (yr); Mean ±SD	6.8 ± 2.47	7.27 ± 3.08	4.93 ± 2.21^*
Weight (kg); Mean ±SD	20.65 ± 7.72	21.65 ± 9.51	17.82 ± 7.37^*
Socio-economic Class:
Upper; n(%)	2(0.24%)	0^ˆ	69(8.02%)^*
Middle; n(%)	87(9.61%)	13(12.74%)^ˆ	324(37.6%)^*
Lower; n(%)	816(90.1%)	89(87.25%)^ˆ	467(54.31%)^*
Age Stratification:
6 mon-2 yr; n(%)	82(9.06%)	8.82%^ˆ ˆ	110(12.7%)^**
>2 yr to 5 yr; n(%)	263(29.06)	24.5%^ˆ ˆ	245(28.4%)^**
>5 yr; n(%)	560(61.8%)	68.62%^ˆ ˆ	505(58.72%)^**
Evaluation of Lifestyle:
Excreta Disposal
Private toilet within house	411(45.41%)	39(38.23%)^ˆ ˆ ˆ	655(76.16%)^***
Private toilet outside house	461(50.93%)	59(57.84%)^ˆ ˆ ˆ	202(23.49%)^***
Public toilets	33(3.64%)	4(3.92%)^ˆ ˆ ˆ	3(0.35%)^***
Source of Drinking water
Tap Water	882(97.50%)	100(98.03%)^ˆ ˆ ˆ	721(83.83%)^***
Tube Well	21(2.24%)	1(0.98%)^ˆ ˆ ˆ	122(14.18%)^***
Others	2(0.24%)	1(0.98%)^ˆ ˆ ˆ	17(1.97%)^***

* p≤0.001

** p≤0.06

*** p≤0.0001

ˆ p≤0.6

ˆ ˆ p≤0.4

ˆ ˆ ˆ p≤0.3

Table 2. Post vaccination adverse events within 30 minutes of duration.

Signs and Symptoms	First dose of vaccination (N = 905); n (%)	Second dose of vaccination (N = 765); n (%)
Pain at site	80 (8.83)	31 (4.05)
Redness at site	3 (0.33)	6 (0.78)
Swelling at site	27 (2.98)	13 (1.69)
Excessive crying	2 (0.22)	2 (2.76)
Fever	31 (3.42)	4 (0.52)
Cough and cold	0	0
Nausea and vomiting	3 (0.33)	1 (0.13)
Pain at site and Fever	7 (0.77)	0
Pain and swelling at site	15 (1.65)	8 (1.04)
Pain at site, Nausea and vomiting	2 (0.22)	0
Pain, Redness and swelling at site	3 (0.33)	3 (0.39)
Pain and Redness at site	3 (0.33)	5 (0.65)
Redness and swelling at site	3 (0.33)	4 (0.52)
Others(Syncope, Abdominal pain)	3 (0.33)	0

Table 3. Clinical events for a period of one year.

Category	Test (N = 905); n (%)	Control (N = 860); n (%)
Typhoid	0	11 (1.27)
Fever without focus	174 (19.22)	207 (24.06)
Fever with Cough and Cold	46 (5.08)	60 (6.97)
Cough, Cold	47 (5.19)	56 (6.51)
Tonsillitis	5 (0.55)	0
Acute Gastroenteritis	31 (3.42)	4 (0.46)
Allergy	2 (0.22)	4 (0.46)
Chicken Pox	2 (0.22)	0
Dengue	7 (0.77)	3 (0.34)
Eye Swelling	2 (0.22)	0
Jaundice	1 (0.11)	1 (0.11)
Malaria	3 (0.33)	0
Measles	1 (0.11)	2 (0.23)
Mumps	1 (0.11)	2 (0.23)
Pain in the abdomen	11 (1.21)	4 (0.46)
Skin Rash	3 (0.33)	2 (0.23)
Total	336 (37.12)	395 (45.93)

Table 4. Febrile episodes in test and control groups post vaccination.

Category
(a) No. of episodes of fever in 12 months; n(%)	Test group (N=174)	Control group (N=207)	p value
1	145(83.3%)	161(77.78%)	0.0013
2	20(11.5%)	13(6.28%)
3	9(5.2%)	33(15.94%)
(b). No. of days; n (%)
More than 3 days	14(8.05%)	47(22.70%)	0.0001
Less than 3 days	160(91.95%)	160(77.29%)
(c). Age stratification; n (%)
6 mon-2 yr	18(10.34%)	55(26.57%)	<0.001
>2 yr-5 yr	46(26.44%)	92(44.44%)
>5 yr	110(63.21%)	60(28.98%)

Figure 1. Overall Episodes of Fever without Focus in Vaccinated Group and Unvaccinated Group.

Figure 2. Geometric Mean Titer of IgG Vi Polysaccharide Antibody at Baseline, 6 weeks and 12 months Post Vaccination.