A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants

Figures & data

Figure 1. Trial profile describing the study subject enrollment.

Table 1. Demographic profile of subjects.

Parameters		Easyfour®-TT (n=122)	Quadrovax® (n=122)	P-value
Gender	Male: Female	1.25	1.17	0.79
Age (week)	Mean ± SD	7.00 ± 1.12	7.11 ± 1.09	0.42
	Range	6.00–10.00	6.00 – 10.00
Weight (Kg)	Mean ± SD	4.30 ± 0.59	4.27 ± 0.60	0.73
	Range	3.30–6.00.	3.30–6.00
Length (cm)	Mean ± SD	55.91 ± 2.95	55.92 ± 2.95	0.98
	Range	46.00 – 65.00	48.00 – 65.00

Table 2. Seroprotection/ Seroconversion rates (SPR) 4 weeks post-vaccination.

Antibody	EasyFour®-TT (n=119)	Quadrovax® (n=120)	Difference in SPR^* % (95 % CI)	P-value
Anti-PRP (≥ 0.15 µg/ml)	100 (96.90,100)	100 (96.90,100)	0	—
Anti-PRP (≥ 1.0 µg/ml)	95.80 (90.54,98.19)	96.67 (91.75,98.70)	0.87 (−3.96, 5.70)	0.72
Anti-Diphtheria (≥0. 1 IU/ml)	99.16 (95.39,99.85)	99.17 (95.44,99.85)	0.01 (−2.30, 2.32)	0.99
Anti-Tetanus (≥0. 1 IU/ml)	100 (96.90,100)	100 (96.80,100)	0	0.96
Anti-PT (≥ 4-Fold Rise)	73.95 (65.40, 81.80)	72.50 (63.91, 79.71)	−1.45 (−12.68, 9.78)	—

Data represented as % of subjects (95% CI), analyzed on immunogenicity study cohort (per-protocol analyses set)

CI=confidence interval, PRP= polyribosylribitol phosphate, PT=pertussis toxin

* Quadrovax® - Easyfour®-TT

Table 3. Geometric mean titer (GMT) and 95% CI.

	GMT (95% CI)
	Easyfour®-TT (n=119)		Quadrovax® (n=120)
Antibody	Pre-vaccination	Post vaccination	Pre-vaccination	Post vaccination	P-value^*
Anti-Diphtheria (IU/ml)	0.03 (0.02, 0.03)	1.70 (1.42, 2.04)	0.03 (0.02, 0.04)	2.07 (1.7,2.53)	0.06
Anti-Tetanus (IU/ml)	1.37 (1.07,1.77)	1.51(1.30,1.75)	1.44 (1.18,1.76)	1.33 (1.18,1.49)	0.06
Anti-PRP (μg/ml) (≥ 0.15 μg/ml)	0.59 (0.51, 0.67)	14.42 (11.15, 18.65)	0.51 (0.44, 0.59)	15.72 (12.04, 20.53)	0.14
Anti-PRP (μg/ml) (≥ 1 μg/ml)	0.59 (0.51,0.67)	14.42 (11.15,18.65)	0.51 (0.44,0.59)	15.72 (12.04,20.53)	0.14
Anti-Pertussis (μg/ml)	5.67 (4.88,6.59)	54.33 (42.37,69.67)	5.85 (4.97,6.89)	52.55 (41.92,65.88)	0.21

Data represent GMT (95% CI) calculated from Intent to treat analysis set

CI=confidence interval, PRP= polyribosyribitol phosphate

* Comparison between post-vaccination GMTs of both groups for each vaccine component.

Table 4. Total incidences of solicited local and systemic AEs reported during the study period (number and percentage of subjects experiencing at least one AE).

	Easyfour®-TT (n=358)	95% (CI)	Quadrovax® (n=360)	95% CI	p-value
Solicited Local AEs
Pain/ Tenderness	92 (25.69%)	21.32–30.61	97 (26.94%)	22.49–31.89	0.70
Redness	24 (6.70%)	4.43–9.94	44 (12.22%)	9.11–16.16	0.01
Swelling	41 (11.45%)	8.43–15.32	58 (16.11%)	12.55–20.41	0.07
Solicited Systemic AEs
Fever	73 (20.39%)	16.41–25.02	94 (26.11%)	21.71–31.03	0.06
Acute allergic reaction	1 (0.27%)	0.01–1.79	2 (0.55%)	0.1–2.22	—
Excessive sleepiness/ Drowsiness	8 (2.23%)	1.04–4.52	14 (3.89%)	2.23–6.59	0.19
Irritability/ restlessness/fussiness	15 (4.19%)	2.45–6.97	28 (7.78%)	5.32–11.17	0.04
Vomiting	8 (2.23%)	1.04–4.52	13 (3.61%)	2.02–6.25	0.27
Diarrhea	7 (1.96%)	0.86–4.17	14 (3.89%)	2.23–6.59	0.12

Data represented as cumulative incidences of AEs reported during the 3 day follow-up after each immunization of the 3-dose vaccination series.

n represents the number of dosing