Safety, immunization coverage and determinants of a new kind of Hepatitis B vaccine firstly applied in Ningbo, China

Figures & data

Figure 1. Subject disposition.

Table 1. Statistical analysis for the association between sample characteristics and immunization with 3 doses of HepB/timely birth dose HepB within 24hours after birth

	acceptance (N)	Non-acceptance (N)
Variable	3-dose HepB /timely birth dose HepB	3-dose HepB /timely birth dose HepB	X^2	P-value
Vaccine dose (μg)		575.17/1.53	<0.001/0.52
5	3106/3419	346/45
10	3451/5009	1653/83
Baby Gender		0.42/0.53	0.51/0.47
Male	3551/4551	1066/65
Female	3006/3877	933/63
Mother's HBsAg status		4.26/2.26	0.04/0.13
negative	6075/7803	1824/114
positive	482/625	175/14
Pregnant weeks (w)		4.56/1.50	0.03/0.22
<37	135/164	31/2
37∼42	6406/8239	1957/124
>42	16/25	11/2
Baby Weight (g)		0.005/0.89	0.94/0.35
<2500	89/116	28/1
2500∼4000	6153/7909	1875/119
>4000	315/403	96/8
Baby Apgar score		0.46/–	0.50/0.29
<7	19/22	4/1
7∼10	6538/8406	1995/127
Mother's city		1190.23/58.14	<0.001/<0.001
Ningbo	4380/4812	462/30
Others	2177/3616	1537/98
Hospital grade		3.77/32.64	0.05/<0.001
Low	2493/3126	712/79
High	4064/5302	1287/49
Hospital classification		0.14/0.56	0.71/0.46
Obstetrics and gynecology hospital	4893/6301	1500/92
general hospital	1664/2127	499/36
Mother's age (years)		1.81/2.12	0.18/0.15
<25	963/1227	287/16
25∼35	5242/6720	1581/100
>35	352/481	131/12
Mother's education years (years)		4.06/0.18	0.04/0.67
≤6	678/867	200/11
7∼12	5021/6419	1494/96
≥13	858/1142	305/21
Delivery way		1.46/0.07	0.23/0.79
natural	3025/3920	953/58
C-section	3532/4508	1046/70
Household income per year (Yuan)	0.17/1.54	0.68/0.21
<10,000	220/287	72/9
10,000∼40,000	3678/4707	1100/70
>40,000	2659/3434	827/49

^a Infants who received 3doses of HepB/timely birth dose of HepB within 24hours after birth.

^b Infants who did not received 3doses of HepB/ timely birth dose of HepB within 24hours after birth.

^c Using Fisher exact test.

^d Ningbo: mothers lived in Ningbo; others: mothers migrated from other cities.

^e low: Country and township hospitals; high: municipal hospitals.

Table 2. Distribution of baby gender, mother's HBsAg status, immunization and infants followed at first, second and third doses of HepB between control and case groups

	Experimental group (N=5104)		Control group (N=3452)
variant	n	%	n	%	P-value
Baby Gender					0.7493
Male	2747	53.82	1870	54.17
Female	2357	46.18	1582	45.83
Mother's HBsAg status					0.0208
Positive	364	7.13	293	8.49
Negative	4740	92.87	3159	91.51
Immunization at different dose				<0.0001
First dose	5104	38.90	3452	34.78
Second dose	4565	34.79	3366	33.92
Third dose	3453	26.31	3106	31.30
Total	13122	100	9924	100
Follow-up at different dose				<0.0001
First dose	5003	39.54	3443	34.87
Second dose	4436	35.06	3346	33.88
Third dose	3214	25.40	3086	31.25
Total	12653	100	9875	100

N = number of infants enrolled into control or experiment group; n = number of infants classified.

Case: infants who received 10 μg-HepB; control: infants who received 5 μg-HepB.

Table 3. Multiple stepwise logistic regression derived odds ratio (and 95% Confidence Intervals) for the model 1 (determinants for 3 doses of HepB) and model 2 (determinants for timely birth dose HepB within 24 hours after birth)

Variable	Odds Ratio	95%CI	P-value	Cox-snell R^2
Model 1 (determinants for 3-dose HepB vaccine)				0.41
Vaccine dose (μg)
5	1	—
10	0.38	0.34–0.44	<0.001
Mother's city		1
Ningbo	1	—
others	0.45	0.42–0.47	<0.001
Model 2 (determinants for timely birth dose HepB vaccine within 24 hours after birth)				0.32
Hospital grade
Low	1	—
High	0.44	0.21–0.93	0.033
Mother's city
Ningbo	1	—
others	0.32	0.15–0.68	0.003

Table 4. Number of subjects with at least one type of reaction

	Control group (NO. followed=9875)			Experimental group (NO. followed=12653)
Type of reaction	First dose	Second dose	Third dose	First dose	Second dose	Third dose
Immediate reaction	0	0	0	0	0	0
Local reaction
Induration	0	0	0	0	1	0
Redness	1	0	0	1	1	0
Swelling	0	0	0	0	0	0
others	0	0	0	0	0	0
System resaction
Diarrhea	0	0	0	1	0	0
Fever	0	1	2	0	0	1
Irritability	0	0	0	0	0	0
others	0	0	0	0	0	0

^a One infant in the control group presented fever at the second dose and diarrhea at the third dose.

Table 5. Reasons for mothers in refusing the 3-dose HepB

	Experimental group (N=165)		Control group (N=35)
Reasons	n	%	n	%	X^2(P)
Number of Mothers who accept and fulfill the survey	153	92.73 (153/165)	30	85.71(30/35)
Known little about vaccine	136	88.89(136/153)	13	43.33(13/30)	22.389(<0.0001)
Worrying about AEs	123	80.39(123/153)	17	56.67(17/30)
I am a migration-mother	95	62.09(95/153)	21	70(21/30)
Others	39	23.64(39/153)	9	30(9/30)

Note. A total of 165 and 35 infants did not receive 3-dose-HepB in 10μg and 5μg groups, respectively.

Case: mothers whose infants did not receive 3-dose-10μg-HepB; control: mothers whose infants did not receive 3-dose-5μg-HepB.