Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Figures & data

Table 1. Study population and vaccine doses received.

Parameter	Total N = 639
Male	342 (53.5%)
Body weight, kg
Median (range)	6.3 (1.5–43.8)
Age when subjects received primary vaccine dose within the PMS
8–16 weeks	367 (57.4%)
>16–24 weeks	110 (17.2%)
>24 weeks – <48 months	99 (15.5%)
Age when subjects received the booster dose within the PMS
48–60 months	40 (6.3%)
>60 months	23 (3.6%)
Number of vaccine doses received
1	302 (47.3%)
2	121 (18.9%)
3	216 (33.8%)
Receiving primary vaccination dose	576 (90.1%)
Dose 1	367 (57.4%)
Dose 2	373 (58.4%)
Dose 3	389 (60.9%)
Receiving booster vaccination dose	63 (9.9%)

All data are presented as number of subjects (%) except where otherwise stated

N, total vaccinated cohort; PMS, post-marketing surveillance

Figure 1. Study flow.

AE, adverse event; SAE, serious adverse event

Table 2. Adverse events (AEs) and adverse drug reactions (ADRs) over the PMS period.

N = 639 (total number of vaccinations = 1,192)
Adverse Event (AE)			Adverse drug reaction (ADR)
AE	Subjects n (%, 95% CI)	AE n (%)	ADR	Subjects n (%, 95% CI)	ADR n (%)
At least one AE	289 (45.2; 41.3–49.2)	587	At least one ADR	83 (13.0; 10.5–15.9)	122
Fever	76 (11.9; 9.5–14.7)	87 (14.8%)	Fever	54 (8.5; 6.4–10.9)	59 (48.4%)
Common cold	49 (7.7; 5.7–10.0)	55 (9.4%)	Irritability	15 (2.3; 1.3–3.8)	16 (13.1%)
URTI	46 (7.2; 5.3–9.5)	57 (9.7%)	Injection-site swelling	8 (1.3; 0.5–2.5)	8 (6.6%)
Coughing	24 (3.8; 2.4–5.5)	24 (4.1%)	Injection-site erythema	7 (1.1; 0.4–2.2)	7 (5.7%)
Irritability	23 (3.6; 2.3–5.4)	25 (4.3%)	Injection-site pain	2 (0.3; 0.0–1.1)	2 (1.6%)
Gastroenteritis	23 (3.6; 2.3–5.4)	26 (4.4%)	Fatigue	2 (0.3; 0.1–1.1)	2 (1.6%)
Rhinorrhoea	23 (3.6; 2.3–5.4)	24 (4.1%)	Vomiting	2 (0.3; 0.1–1.1)	2 (1.6%)
Bronchitis	23 (3.6; 2.3–5.4)	23 (3.9%)	Rash	2 (0.3; 0.1–1.1)	2 (1.6%)
Bronchiolitis	22 (3.4; 2.3–5.4)	23 (3.9%)	Erythema	2 (0.3; 0.1–1.1)	2 (1.6%)
Diarrhea	17 (2.7; 1.6–4.2)	19 (3.2%)	Injection-site induration	2 (0.3; 0.0–1.1)	2 (1.6%)
			Injection-site reaction	1 (0.2; 0.0–0.9)	1 (0.8%)
			Kawasaki disease	1 (0.2; 0.0–0.9)	2 (1.6%)

N = total number of infants receiving study vaccine overall (any dose and by specific dose); subject n (%): number (percentage) of subjects with an AE or ADR; AE n (%): number of AEs and (%); ADR n (%): number of ADRs and (%); AE, adverse event; URTI, upper respiratory tract infection.

All % are based on the number of subjects or AEs or ADRs for the respective period.

Subjects may experience more than one AE category.

95% CI: 95% confidence interval; ADR, adverse drug reaction; AE, adverse event; PMS, post-marketing surveillance; URTI, upper respiratory tract infection.

Table 3. Unexpected adverse events and adverse drug reactions over the PMS period.

N = 639 (total number of vaccinations = 1,192)
Adverse Event (AE)			Adverse drug reaction (ADR)
AE	Subjects n (%, 95% CI)	AE n (%)	ADR	Subjects n (%, 95% CI)	ADR n (%)
At least one unexpected AE	210 (32.9; 29.2–36.7)	350	At least one unexpected ADR	12 (1.9; 1.0–3.3)	17
Common cold	49 (7.7; 5.7–10.0)	55 (15.7%)	Fatigue	2 (0.3; 0.0–1.1)	2 (11.8%)
URTI	46 (7.2; 5.3–9.5)	57 (16.3%)	Kawasaki disease	1 (0.2; 0.0–0.9)	2 (11.8%)
Gastroenteritis	23 (3.6; 2.3–5.4)	26 (7.4%)	Dizziness	1 (0.2; 0.0–0.9)	1 (5.9%)
Rhinorrea	23 (3.6; 2.3–5.4)	24 (6.9%)	URTI	1 (0.2; 0.0–0.9)	1 (5.9%)
Bronchiolitis	22 (3.4; 2.2–5.2)	23 (6.6%)	Bronchiolitis	1 (0.2; 0.0–0.9)	1 (5.9%)
Otitis media	15 (2.4; 1.3–3.8)	16 (4.6%)	Laryngitis	1 (0.2; 0.0–0.9)	1 (5.9%)
Pneumonia	10 (1.6; 0.8–2.9)	10 (2.9%)	Tonsillitis	1 (0.2; 0.0–0.9)	1 (5.9%)
			Pharyngitis	1 (0.2; 0.0–0.9)	1 (5.9%)
			Constipation	1 (0.2; 0.0–0.9)	1 (5.9%)
			Flank Pain	1 (0.2; 0.0–0.9)	1 (5.9%)
			Conjunctivitis	1 (0.2; 0.0–0.9)	1 (5.9%)
			Insomnia	1 (0.2; 0.0–0.9)	1 (5.9%)
			Sleep disorder	1 (0.2; 0.0–0.9)	1 (5.9%)
			Feeding disorder in child	1 (0.2; 0.0–0.9)	1 (5.9%)
			Viral infection	1 (0.2; 0.0–0.9)	1 (5.9%)

N = total number of infants receiving study vaccine overall (any dose and by specific dose); subject n (%): number (percentage) of subjects with an AE or ADR; AE n (%): number of AEs and (%); ADR n (%): number of ADRs and (%).

All % are based on the number of subjects or AEs or ADRs for the respective period.

Subjects may experience more than one AE category.

95% CI: 95% confidence interval; ADR, adverse drug reaction; AE, adverse event; PMS, post-marketing surveillance; URTI, upper respiratory tract infection.

Table 4. Serious adverse events and serious adverse drug reactions over the PMS period.

N = 639 (total number of vaccinations = 1,192)
Serious Adverse Event (SAE)			Serious Adverse drug reaction (ADR)
SAE	Subjects n (%, 95% CI)	SAE n (%)	Serious ADR	Subjects n (%, 95% CI)	Serious ADR n (%)
At least one SAE	26 (4.1; 2.7–5.9)	34	At least one serious ADR	2 (0.3; 0.0–1.1)	2
Bronchiolitis	8 (1.3; 0.5–2.5)	8 (23.5%)	Fever	1 (0.2; 0.0–0.9)	1 (50.0%)
Gastrointestinal infection	7 (1.1; 0.4–2.2)	9 (26.5%)	Kawasaki disease	1 (0.2; 0.0–0.9)	1 (50.0%)
Gastroenteritis	5 (0.8; 0.3–1.8)	5 (14.7%)
Pneumonia	4 (0.6; 0.2–1.6)	4 (11.8%)
Colitis	3 (0.5; 0.1–1.4)	3 (8.8%)
URTI	1 (0.2; 0.0–0.9)	1 (2.9%)
Common cold	1 (0.2; 0.0–0.9)	1 (2.9%)
Bronchitis	1 (0.2; 0.0–0.9)	1 (2.9%)
Pharyngotonsillitis	1 (0.2; 0.0–0.9)	1 (2.9%)
Otitis media	1 (0.2; 0.0–0.9)	1 (2.9%)
Viral infection	1 (0.2; 0.0–0.9)	1 (2.9%)
Sepsis	1 (0.2; 0.0–0.9)	1 (2.9%)
Fever	1 (0.2; 0.0–0.9)	1 (2.9%)
Urinary tract infection	1 (0.2; 0.0–0.9)	1 (2.9%)
Cystitis	1 (0.2; 0.0–0.9)	1 (2.9%)
Pyelonephritis	1 (0.2; 0.0–0.9)	1 (2.9%)
Kawasaki disease	1 (0.2; 0.0–0.9)	1 (2.9%)
Cervical lymphadenitis	1 (0.2; 0.0–0.9)	1 (2.9%)

N = total number of infants receiving study vaccine overall (any dose and by specific dose); subject n (%): number (percentage) of subjects with an SAE or serious ADR; SAE n (%): number of SAEs and (%); Serious ADR n (%): number of Serious ADRs and (%).

All % are based on number of subjects or SAEs or Serious ADRs for the respective period.

Subjects may experience more than one SAE category.

95% CI: 95% confidence interval; ADR, adverse drug reaction; PMS, post-marketing surveillance; SAE, serious adverse event; URTI, upper respiratory tract infection.

Table 5. Subject characteristics and incidence of adverse events (AEs).

Characteristic	Adverse Event n	Subjects with Adverse Event n (%, 95% CI)	P-Value
Renal impairment
Yes (N = 4)	6	3 (75.0; 19.4–99.4)	0.333^a
No (N = 635)	581	286 (45.0; 41.1–49.0)
Gender
Male (N = 342)	314	162 (47.4; 42.0–52.8)	0.243
Female (N = 297)	273	127 (42.8; 37.1–48.6)
Age
Primary vaccination			0.080
8–16 weeks (N = 367)	325	152 (41.4; 36.3–46.7)
>16–24 weeks (N = 110)	124	58 (52.7; 43.0–62.3)
>24 weeks – <48 months (N = 99)	80	48 (48.5; 38.3–58.8)
Booster			0.225
48–60 months (N = 40)	33	22 (55.0; 38.5–70.7)
>60 months (N = 23)	25	9 (39.1; 19.7–61.5)
Previous medical condition
Yes (N = 256)	237	115 (44.9; 38.7–51.2)	0.899
No (N = 383)	350	174 (45.4; 40.4–50.6)
Current medical condition
Yes (N = 148)	152	65 (43.9; 35.8–52.3)	0.715
No (N = 491)	435	224 (45.6; 41.2–50.1)
Previous vaccination
Yes (N = 242)	201	98 (40.5; 34.3–47.0)	0.057
No (N = 396)	386	191 (48.2; 43.2–53.3)
Concomitant vaccination
Yes (N = 567)	527	254 (44.8; 40.7–49.0)	0.540
No (N = 72)	60	35 (48.6; 36.7–60.7)
Concomitant medication
Yes (N = 317)	490	235 (74.1; 68.9–78.9)	<0.0001
No (N = 322)	97	54 (16.8; 12.9–21.3)
Number of vaccine doses received
1 (N = 302)	200	117 (38.7; 33.2–44.5)	0.006
2 (N = 121)	158	65 (53.7; 44.4–62.8)
3 (N = 216)	229	107 (49.5; 42.7–56.4)

^a P-values calculated using Fisher exact test

Adverse event n (%): number of AEs; Subjects with Adverse event n (%): number (percentage) of subjects with an AE with 95% confidence intervals.

Subjects may experience more than one AE category.

95% CI: 95% confidence interval; AE, adverse event.

Figure 2. Focus on the patient.