Factors associated with reported pain on injection and reactogenicity to an OMV meningococcal B vaccine in children and adolescents

Figures & data

Table 1. Demographics of trial participants

Ethnicity	n	%
NZ European	214	39
Maori	156	28
Pacific	151	27
Asian	24	4
Other	9	2
Age	n	%
8 years	100	18
9 years	146	26
10 years	147	27
11 years	97	18
12 years	64	12
Socioeconomic Deprivation	n	%
1 (High deprivation)	174	31
2	149	27
3	76	14
4	34	6
5	0	0
6	16	3
7	69	12
8	36	7
9	0	0
10 (Low deprivation)	0	0
Gender	n	%
Male	259	47
Female	295	53
Vaccine by manufacture site	n	%
Norway Cohort A	241	44
Norway Cohort B	63	11
Italy Cohort B	250	45
Body Mass Index	n	%
Underweight (<5^th percentile)	315	56.9
Normal Weight (5^th–<85^th percentile)	200	36.1
Overweight (85^th–<95^th percentile)	24	4.3
Obese (≥ 95^th percentile)	15	2.7
	Mean 14.5	Range 8.4 – 30.2
Vaccinator	Dose 1 n (%)
1	109 (19.9)
2	165 (29.8)
3	80 (14.4)
4	5 (0.9)
5	0
6	34 (6.2)
7	51 (9.3)
8	103 (18.8
TOTAL	547

¹ The he socioeconomic deprivation decile of the school has been used as a proxy for individual socioeconomic status for the analysis. Decile one is the most deprived and decile 10 the least. The decile indicates to what extent the school draws its students from the most socioeconomically deprived communities. Decile 1 schools are the 10% of schools with the highest proportion of students from low socio-economic communities and decile 10 are the 10% of schools with the lowest proportion of these students. More children who come from high deprivation decile schools are, as individuals, likely to be from high deprivation backgrounds.

Table 2. Odds Ratios for variables associated with the reporting of pain on injection following multivariable analysis

	Pain on injection
Variable	Odds Ratio (95% CI)	P value
European/Other	1.0	0.002
Asian	0.7 (0.3–1.7)
Maori	0.5 (0.3 – 0.7)
Pacific Island	0.5 (0.3 – 0.8)
Vaccinator 7	1.0	<0.0001
Vaccinator 6	3.9 (2.1 – 7.4)
Vaccinator 5	5.4 (2.6 – 11.4)
Vaccinator 4	1.5 (0.2 – 9.7)
Vaccinator 3	8.6 (3.6 – 20.5)
Vaccinator 2	6.6 (3.4 – 12.8)
Vaccinator 1	4.7 (2.1 – 10.9)
Norwegian produced vaccine cohort B	1.0	<0.0001
Norwegian produced vaccine cohort A	2.5 (1.2 – 5.3)
Italian produced vaccine	0.5 (0.3 – 0.87)
BMI Mass(Kg) / Height (m)^2	0.9 (0.89 – 0.97)	0.43

¹ Odds of increasing by 1 unit of Mass (Kg) / height (m)².

Figure 1. Summary of ethnicity and reactogenicity results from univariable analysis Injection site pain P = 0.0001, Erythema P = <0.0001, Swelling P = 0.07, Induration P = 0.4, Pain on injection P = 0.03.

Table 3. Odds Ratios for variables associated with the reporting of pain following injection, erythema, swelling and induration following dose one of NZ meningococcal B vaccine following multivariable analysis

Variable	Pain following injection		Local erythema		Injection site swelling		Injection site induration
	Odds Ratio (95% CI)	P value	Odds Ratio (95% CI)	P value	Odds Ratio (95% CI)	P value	Odds Ratio (95% CI)	P value
NZ European/Other	1.0	0.0004	1.0	0.007	1.0	0.11	1.0	0.10
Asian	0.7 (0.3 – 1.6)		0.6 (0.2 – 1.4)		2.45 (0.94 – 6.40)		1.94 (0.83 – 4.51)
Maori	0.9 (0.6 – 1.4)		0.6 (0.4 – 1.0)		1.33 (0.76 – 2.34)		1.45 (0.90 – 2.26)
Pacific Island	0.4 (0.3 – 0.7)		0.4 (0.3 – 0.7)		0.77 (0.40 – 1.50)		0.85 (0.50 – 1.45)
Vaccinator 8	1.0	0.007	1.0	0.002	1.0	0.02	1.0	0.13
Vaccinator 7	2.6 (1.4 – 5.0)		5.4 (2.7 – 10.8)		3.26 (1.26 – 8.44)		2.71 (1.27 – 5.78)
Vaccinator 6	1.6 (0.8 – 3.5)		1.8 (0.8 – 4.1)		2.64 (0.88 – 7.90)		1.67 (0.67 – 4.17)
Vaccinator 4	0.3 (0.15 – 2.1)		2.4 (0.335 – 18.2)		NC		NC
Vaccinator 3	1.8 (0.7 – 4.2)		3.1 (1.2 – 7.8)		6.05 (1.82 – 20.04)		2.40 (0.86 – 6.55)
Vaccinator 2	1.7 (0.9 – 3.3)		2.7 (1.3 – 5.6)		3.52 – 1.35 – 9.15)		1.60 (0.071 – 3.62)
Vaccinator 1	0.97 (0.4 – 2.2)		2.1 (0.9 – 5.0)		2.37 (0.70 – 8.00)		1.70 (0.63 – 4.47)
Norwegian produced vaccine cohort B	1.0	0.52	1.0	0.4	1.0	0.27	1.0	0.82
Norwegian produced vaccine cohort A	0.7 (0.3 – 1.5)		0.9 (0.4 – 2.1)		2.43 (0.83 – 7.08)		0.97 (0.40 – 2.37)
Italian produced vaccine	1.0 (0.6 – 1.7)		1.3 (0.7 – 2.4)		1.55 (0.68 – 3.52)		1.16 (0.63–2.13)
BMI Mass(Kg) / Height (m)	0.9 (0.89 – 0.98)	0.003	1.0 (0.9 – 1.0)	0.3	0.95 (0.88–1.02)	0.12	0.97 ( 0.92 – 1.03)	0.30

¹ Not calculated as Vaccinator 4 vaccinated few individuals, ORs could not be calculated for swelling and induration.

² Odds of increasing by 1 unit of Mass (Kg)/height (m)².

Table 4. Summary of pain on injection and reactogenicity with severity for all doses

Event	None (%)	Any (if ≥ 1) (%)	Mild (%)	Moderate (%)	Severe (%)
Inj Pain Dose 1 (N = 547)	50 (9.1)	497 (90.9)	275 (50.3)	148 (27.1)	74 (13.5)
Inj Pain Dose 2 (N = 532)	74 (13.9)	458 (86.1)	246 (46.2)	160 (30.1)	52 (9.8)
Inj Pain Dose 3 (532)	76 (14.5)	449 (85.5)	222 (42.3)	162 (30.9)	65 (12.4)
Pain Dose 1 (N = 547)	47 (8.5)	500 (91.4)	252 (45.5)	201 (36.3)	47 (8.5)
Pain Dose 2 (N = 534)	128 (23.1)	406 (76.0)	222 (40.1)	151 (27.3)	33 (6.0)
Pain Dose 3 (N = 524)	172 (31.0)	352 (67.2)	206 (37.2)	120 (21.7)	26 (4.7)
	None (0 mm)	Any	Mild (10–25 mm)	Mod (26–50 mm)	Severe (>50 mm)
Erythema Dose 1 (N = 547)	310 (56.7)	237 (43.3)	58 (10.6)	18 (3.3)	7 (1.3)
Erythema Dose 2 (N = 532)	349 (65.6)	183 (34.4)	38 (7.1)	14 (3.0)	9 (1.7)
Erythema Dose 3 (N = 526)	355 (67.5)	171 (32.5)	21 (4.0)	10 (1.9)	2 (0.4)
Swelling Dose 1 (N = 547)	452 (82.6)	95 (17.4)	20 (3.6)	23 (4.2)	8 (1.5)
Swelling Dose 2 (N = 534)	442 (82.8)	92 (17.2)	19 (3.6)	11 (2.0)	6 (1.1)
Swelling Dose 3 (N = 525)	445 (84.8)	80 (15.2)	10 (1.9)	4 (0.8)	4 (0.8)
Induration Dose 1 (N = 547)	385 (70.4)	162 (29.6)	33 (6.0)	29 (5.3)	5 (0.9)
Induration Dose 2 (N = 533)Induration Dose 3 (N = 526)	407 (76.4)414 (78.7)	126 (23.6)112 (21.3)	41 (7.7)19 (3.6)	14 (2.6)12 (2.3)	3 (0.6)4 (0.8)

^a Mild, transient with no limitation in normal daily activity.

^b Moderate, some limitation in normal daily activity.

^c Severe, unable to perform normal daily activity.

^d Definition of severity as per Hosking 2007⁹.

Hosking J, Rasanathan K, Mow FC, Jackson C, Martin D, O'Hallahan J, Oster P, Ypma E, Reid S, Aaberge I, et al. Immunogenicity, reactogenicity, and safety of a P1.7b,4 strain-specific serogroup B meningococcal vaccine given to preteens. Clin Vaccine Immunol 2007; 14:1393-9; PMID:17898183; http://dx.doi.org/10.1128/CVI.00167-07

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