A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India

Figures & data

Figure 1. Methodology for the process of collecting adverse events data in active and passive surveillance.

Table 1. Age group and severity-wise classification of adverse events (AE) in active surveillance

A Period-I (Feb2016 to Oct2016)
Age group/Adverse Events	≥6 months to ≤45 years (N = 4991)				≥6 months to ≤2 years (N = 2298)			≥2 to ≤45 years (N = 2693)
	Overall AEs n (%)	Mild n (%)	Moderate n (%)	Severe n (%)	Mild n (%)	Moderate n (%)	Severe n (%)	Mild n (%)	Moderate n (%)	Severe n (%)
Solicited-Systemic AEs
Fever^#	459 (9.20)	430 (8.62)	24 (0.48)	5 (0.10)	156 (6.79)	13 (0.57)	5 (0.22)	274 (10.17)	11 (0.41)	0
Pruritus/Itching	54 (1.08)	53 (1.06)	1 (0.02)	0	18 (0.78)	0	0	35 (1.29)	1 (0.03)	0
Solicited-Local AEs
Pain	412 (8.25)	400 (8.01)	12 (0.24)	0	182 (7.92)	6 (0.26)	0	218 (8.09)	6 (0.22)	0
Swelling*	199 (3.99)	197 (3.95)	2 (0.04)	0	72 (3.13)	1 (0.04)	0	125 (4.64)	1 (0.03)	0
Rashes	1 (0.02)	1 (0.02)	0	0	0	0	0	1 (0.03)	0	0
Unsolicited AEs
Cough	14 (0.28)	14 (0.28)	0	0	6 (0.26)	0	0	8 (0.29)	0	0
Cold	5 (0.10)	5 (0.10)	0	0	4 (0.17)	0	0	1 (0.04)	0	0
Crying	3 (0.06)	1 (0.02)	2 (0.04)	0	0	0	0	1 (0.03)	2 (0.07)	0

B. Period-II (Apr 2017 to Oct 2018)
Age group/Severity Classification of AEs	≥ 6 months to ≤ 45 years (N = 3898)				≥ 6 months to ≤ 2 years (N = 1874)				≥ 2 to ≤ 45 years (N = 2024)
	Brighton Classification			Overall AEs n = 596	Brighton Classification			Overall AEs n = 284	Brighton Classification		Overall AEs n = 312
	Level 1 n (%)	Level 2 n (%)	Level 3 n (%)		Level 1 n (%)	Level 2 n (%)	Level 3 n (%)		Level 1 n (%)	Level 2 n (%)		Level 3 n (%)
Solicited-Systemic AEs
Fever^#	336(8.62)	0	0	336	140(7.47)	–	–	140	196(9.68)	–	–	196
Solicited-Local AEs
Pain*	205(5.26)	0	0	205	112(5.98)	–	–	112	93(4.59)	–	–	93
Swelling^¥	54(1.39)	0	0	54	31(1.65)	–	–	31	23(1.14)	–	–	23
Unsolicited AEs
GCS	1 (0.03)	0	0	1	1(0.05)	–	–	1	0	–	–	0

Classification Ranges:^# Fever: Mild: (99.0º–101.1ºF), Moderate (101.2º–102ºF), Severe (102.1º–104ºF), *Swelling: Mild (< 1 cm) Moderate (>1 cm)

GCS: Generalized clonic seizures

Classification Ranges:

^#Fever is defined as the endogenous elevation of at least one measured body temperature of≥38°̊C.

*Immunization site Pain: Level 1, Level 2, and level 3.

^¥Swelling at or near injection site: Level 1 and Level 2.

Figure 2. Adverse events distribution between age groups in active surveillance.