Acellular vaccines for preventing whooping cough in children

Linjie Zhang; Sílvio OM Prietsch; Inge Axelsson; Scott A Halperin

doi:10.1002/14651858.CD001478.pub6

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Figure 1

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 1 Primary series non‐completion due to adverse events.

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Analysis 1.2

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 2 Death (all causes).

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Analysis 1.3

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 3 Death (infection).

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Analysis 1.4

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 4 Encephalopathy.

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Analysis 1.5

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 5 Convulsions.

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Analysis 1.6

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 6 Hypotonic hyporesponsive episodes.

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Analysis 1.7

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 7 Anorexia.

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Analysis 1.8

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 8 Drowsiness.

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Analysis 1.9

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 9 Fever.

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Analysis 1.10

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 10 Irritability/fretfulness.

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Analysis 1.11

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 11 Prolonged crying.

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Analysis 1.12

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 12 Vomiting.

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Analysis 1.13

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 13 Pain/tenderness.

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Analysis 1.14

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 14 Redness.

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Analysis 1.15

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 15 Swelling/induration.

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Analysis 2.1

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 1 Primary series non‐completion due to adverse events.

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Analysis 2.2

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 2 Death (all causes).

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Analysis 2.3

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 3 Death (infection).

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Analysis 2.4

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 4 Encephalopathy.

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Analysis 2.5

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 5 Convulsions.

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Analysis 2.6

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 6 Hypotonic hyporesponsive episodes.

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Analysis 2.7

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 7 Anorexia.

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Analysis 2.8

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 8 Drowsiness.

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Analysis 2.9

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 9 Fever.

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Analysis 2.10

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 10 Irritability/fretfulness.

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Analysis 2.11

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 11 Prolonged crying.

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Analysis 2.12

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 12 Vomiting.

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Analysis 2.13

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 13 Pain/tenderness.

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Analysis 2.14

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 14 Swelling/induration.

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Analysis 2.15

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 15 Redness.

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Comparison 1. Safety: acellular versus whole‐cell pertussis vaccines

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary series non‐completion due to adverse events Show forest plot	14	108909	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.12, 0.43]

2 Death (all causes) Show forest plot	16	122451	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.62, 1.22]

2.1 Primary series	16	122451	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.62, 1.22]
3 Death (infection) Show forest plot	13	34498	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.23, 4.16]

3.1 Primary series	13	34498	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.23, 4.16]
4 Encephalopathy Show forest plot	9	113762	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

4.1 Primary series	9	113762	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Convulsions Show forest plot	26		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Primary series	15	124387	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.31, 0.73]
5.2 Booster	11	2647	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.02, 11.20]
6 Hypotonic hyporesponsive episodes Show forest plot	18		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 Primary series	11	121573	Risk Ratio (M‐H, Random, 95% CI)	0.26 [0.08, 0.81]
6.2 Booster	7	2487	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
7 Anorexia Show forest plot	26		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Primary series: Dose 1	11	19632	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.32, 0.57]
7.2 Primary series: Dose 2	8	18501	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.33, 0.60]
7.3 Primary series: Dose 3	9	18646	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.43, 0.60]
7.4 aP booster (previous wP) versus wP booster (previous wP)	14	1939	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.30, 0.54]
7.5 aP booster (previous aP) versus wP booster (previous wP)	4	8447	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.31, 0.58]
8 Drowsiness Show forest plot	25		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 Primary series: Dose 1	12	20490	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.45, 0.68]
8.2 Primary series: Dose 2	9	19308	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.35, 0.60]
8.3 Primary series: Dose 3	10	19430	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.40, 0.77]
8.4 aP booster (previous wP) versus wP booster (previous wP)	13	2254	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.41, 0.56]
8.5 aP booster (previous aP) versus wP booster (previous wP)	3	8367	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.44, 0.54]
9 Fever Show forest plot	46		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 Primary series: Dose 1	19	23267	Risk Ratio (M‐H, Random, 95% CI)	0.17 [0.13, 0.20]
9.2 Primary series: Dose 2	17	22001	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.26, 0.37]
9.3 Primary series: Dose 3	17	21731	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.30, 0.38]
9.4 aP booster (previous wP) versus wP booster (previous wP)	24	3381	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.26, 0.43]
9.5 aP booster (previous aP) versus wP booster (previous wP)	8	9879	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.22, 0.55]
10 Irritability/fretfulness Show forest plot	33		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 Primary series: Dose 1	15	20707	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.42, 0.56]
10.2 Primary series: Dose 2	12	19429	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.41, 0.56]
10.3 Primary series: Dose 3	13	19511	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.47, 0.59]
10.4 aP booster (previous wP) versus wP booster (previous wP)	17	2596	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.28, 0.47]
10.5 aP booster (previous aP) versus wP booster (previous wP)	6	9856	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.44, 0.51]
11 Prolonged crying Show forest plot	14		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

11.1 Primary series: Dose 1	8	17184	Risk Ratio (M‐H, Random, 95% CI)	0.15 [0.11, 0.19]
11.2 Primary series: Dose 2	6	16347	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.24, 0.35]
11.3 Primary series: Dose 3	7	16545	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.24, 0.46]
11.4 aP booster (previous wP) versus wP booster (previous wP)	6	996	Risk Ratio (M‐H, Random, 95% CI)	0.21 [0.10, 0.48]
11.5 aP booster (previous aP) versus wP booster (previous wP)	2	7943	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.02, 3.12]
12 Vomiting Show forest plot	15		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 Primary series: Dose 1	8	11450	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.66, 0.88]
12.2 Primary series: Dose 2	7	10985	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.45, 0.86]
12.3 Primary series: Dose 3	7	10813	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.04]
12.4 aP booster (previous wP) versus wP booster (previous wP)	6	744	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.22, 1.11]
12.5 aP booster (previous aP) versus wP booster (previous wP)	1	86	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.10, 11.34]
13 Pain/tenderness Show forest plot	35		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 Primary series: Dose 1	13	14180	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.16, 0.25]
13.2 Primary series: Dose 2	11	13186	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.15, 0.22]
13.3 Primary series: Dose 3	12	13333	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.17, 0.24]
13.4 aP booster (previous wP) versus wP booster (previous wP)	21	3051	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.36, 0.53]
13.5 aP booster (previous aP) versus wP booster (previous wP)	5	2263	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.32, 0.58]
14 Redness Show forest plot	35		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

14.1 Primary series: Dose 1	13	7153	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.23, 0.39]
14.2 Primary series: Dose 2	12	6427	Risk Ratio (M‐H, Random, 95% CI)	0.39 [0.29, 0.51]
14.3 Primary series: Dose 3	13	6632	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.41, 0.54]
14.4 aP booster (previous wP) versus wP booster (previous wP)	21	3055	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.44, 0.59]
14.5 aP booster (previous aP) versus wP booster (previous wP)	5	2263	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.52, 0.80]
15 Swelling/induration Show forest plot	39		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

15.1 Primary series: Dose 1	15	14612	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.19, 0.31]
15.2 Primary series: Dose 2	14	13779	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.28, 0.45]
15.3 Primary series: Dose 3	15	13916	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.29, 0.54]
15.4 aP booster (previous wP) versus wP booster (previous wP)	22	3301	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.46, 0.57]
15.5 aP booster (previous aP) versus wP booster (previous wP)	6	2421	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.58, 0.80]

Comparison 1. Safety: acellular versus whole‐cell pertussis vaccines

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Comparison 2. Safety: acellular vaccines versus placebo/DT

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary series non‐completion due to adverse events Show forest plot	4	25901	Risk Ratio (M‐H, Random, 95% CI)	0.70 [0.38, 1.29]

2 Death (all causes) Show forest plot	4	25901	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.26, 4.42]

2.1 Primary series	4	25901	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.26, 4.42]
3 Death (infection) Show forest plot	4	25902	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.19, 7.80]

3.1 Primary series	4	25902	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.19, 7.80]
4 Encephalopathy Show forest plot	2	18650	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

4.1 Primary series	2	18650	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Convulsions Show forest plot	4	25901	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.12, 1.69]

5.1 Primary series	4	25901	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.12, 1.69]
6 Hypotonic hyporesponsive episodes Show forest plot	4	25901	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.02, 5.13]

6.1 Primary series	4	25901	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.02, 5.13]
7 Anorexia Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Primary series: Dose 1	2	11526	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.93, 1.20]
7.2 Primary series: Dose 2	2	11386	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.66, 1.46]
7.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.91, 1.26]
8 Drowsiness Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 Primary series: Dose 1	2	10954	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.96, 1.11]
8.2 Primary series: Dose 2	2	10620	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.91, 1.09]
8.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.91, 1.15]
9 Fever Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 Primary series: Dose 1	3	11255	Risk Ratio (M‐H, Random, 95% CI)	1.18 [0.73, 1.90]
9.2 Primary series: Dose 2	3	10853	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.91, 1.11]
9.3 Primary series: Dose 3	2	7654	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.94, 1.13]
10 Irritability/fretfulness Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 Primary series: Dose 1	2	11526	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.93, 1.05]
10.2 Primary series: Dose 2	2	11386	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.93, 1.03]
10.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.91, 1.02]
11 Prolonged crying Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

11.1 Primary series: Dose 1	2	11525	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.71, 2.34]
11.2 Primary series: Dose 2	2	11386	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.83, 1.40]
11.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.66, 1.68]
12 Vomiting Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 Primary series: Dose 1	2	11526	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.94, 1.30]
12.2 Primary series: Dose 2	2	11386	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.76, 1.07]
12.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.75, 1.13]
13 Pain/tenderness Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 Primary series: Dose 1	2	11451	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.78, 1.32]
13.2 Primary series: Dose 2	2	11202	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.81, 1.51]
13.3 Primary series: Dose 3	1	7623	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.87, 1.16]
14 Swelling/induration Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

14.1 Primary series: Dose 1	3	11652	Risk Ratio (M‐H, Random, 95% CI)	1.29 [0.62, 2.68]
14.2 Primary series: Dose 2	3	11401	Risk Ratio (M‐H, Random, 95% CI)	2.08 [0.54, 8.01]
14.3 Primary series: Dose 3	2	7816	Risk Ratio (M‐H, Random, 95% CI)	1.13 [1.07, 1.20]
15 Redness Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

15.1 Primary series: Dose 1	1	3724	Risk Ratio (M‐H, Random, 95% CI)	3.03 [0.38, 23.85]
15.2 Primary series: Dose 2	1	3535	Risk Ratio (M‐H, Random, 95% CI)	8.76 [3.89, 19.72]
15.3 Primary series: Dose 3	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Safety: acellular vaccines versus placebo/DT

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