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Cochrane Database of Systematic Reviews

Vacunas acelulares para prevenir la tos ferina en niños

Information

DOI:
https://doi.org/10.1002/14651858.CD001478.pub6Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 17 September 2014see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Acute Respiratory Infections Group

Copyright:
  1. Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Linjie Zhang

    Correspondence to: Faculty of Medicine, Federal University of Rio Grande, Rio Grande, Brazil

    [email protected]

  • Sílvio OM Prietsch

    Faculty of Medicine, Federal University of Rio Grande, Rio Grande, Brazil

  • Inge Axelsson

    Östersund County Hospital, Östersund, Sweden

    Department of Health Sciences, Mid Sweden University, Östersund, Sweden

  • Scott A Halperin

    Canadian Center for Vaccinology, Halifax Dalhousie University, IWK Health Centre, Halifax, Canada

Contributions of authors

Inge Axelsson (IA) contributed to updating the Background section and the section "Agreements and disagreements with other studies or reviews" in the Discussion section.
Silvio Prietsch (SP) was responsible for updating the Background section. He participated in study selection, quality assessment and data collection for the updated review. He also provided input to updating the section Risk of bias in included studies.
Linjie Zhang (LZ) was responsible for study selection, quality assessment, data collection and data analysis for the updated review. He was also responsible for updating the Abstract, Methods, Results, Discussion and References. He contributed to updating the Background section.
Scott Halperin (SH) performed a critical review of the manuscript and provided input to updating the Discussion section.
The final version of the updated review was approved by all review authors.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • UK Department of Health Cochrane Incentive Scheme 2008, UK.

    This updated review received an award from the UK Department of Health Cochrane Incentive Scheme 2008

Declarations of interest

Inge Axelsson was in part paid by the Research and Development Unit, Jämtland County Council, Östersund, Sweden. "In the last 10 years, I have been a Clinical Investigator in a trial of an infant combination vaccine containing acellular pertussis (aP) vaccine from Sanofi Pasteur MSD but I have not received any fee from any pharmaceutical company".

Scott A Halperin has undertaken clinical trials of acellular pertussis vaccines for most manufacturers of these products including GlaxoSmithKline, Sanofi Pasteur, Novartis and Wyeth. He has given Continuing Medical Education talks (not as part of a manufacturers' speakers bureau) for which an honorarium has been paid. He has served on occasional ad hoc advisory boards of vaccine manufacturers but does not have any ongoing consultancies.

Linjie Zhang: none known.

Sílvio OM Prietsch: none known.

Acknowledgements

Thanks to Sarah Thorning, Trials Search Co‐ordinator of the Cochrane Acute Respiratory Infections (ARI) Group, for performing the updated search and to Elizabeth Dooley, Managing Editor of the Cochrane ARI Group, for continuous support. Owen Tinnion and Mark Hanlon were responsible for the first published version of this review.

Version history

Published

Title

Stage

Authors

Version

2014 Sep 17

Acellular vaccines for preventing whooping cough in children

Review

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

https://doi.org/10.1002/14651858.CD001478.pub6

2012 Mar 14

Acellular vaccines for preventing whooping cough in children

Review

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

https://doi.org/10.1002/14651858.CD001478.pub5

2011 Jan 19

Acellular vaccines for preventing whooping cough in children

Review

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

https://doi.org/10.1002/14651858.CD001478.pub4

2009 Jul 08

Acellular vaccines for preventing whooping cough in children

Review

Owen Tinnion, Mark Hanlon

https://doi.org/10.1002/14651858.CD001478.pub2

2008 Apr 23

Acellular vaccines for preventing whooping cough in children

Review

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

https://doi.org/10.1002/14651858.CD001478.pub3

1999 Apr 26

Acellular vaccines for preventing whooping cough in children

Review

Owen Tinnion, Mark Hanlon

https://doi.org/10.1002/14651858.CD001478

Notes

This review was previously withdrawn from The Cochrane Library in Issue 3, 2006. The electronic searches had been conducted in 1998 and the lead author was unable to update the review. In May 2008 this review was taken over and updated by a new team of review authors.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 1

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

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 1 Primary series non‐completion due to adverse events.
Figures and Tables -
Analysis 1.1

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 2 Death (all causes).
Figures and Tables -
Analysis 1.2

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 3 Death (infection).
Figures and Tables -
Analysis 1.3

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 4 Encephalopathy.
Figures and Tables -
Analysis 1.4

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 5 Convulsions.
Figures and Tables -
Analysis 1.5

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 6 Hypotonic hyporesponsive episodes.
Figures and Tables -
Analysis 1.6

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 7 Anorexia.
Figures and Tables -
Analysis 1.7

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 8 Drowsiness.
Figures and Tables -
Analysis 1.8

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 9 Fever.
Figures and Tables -
Analysis 1.9

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 10 Irritability/fretfulness.
Figures and Tables -
Analysis 1.10

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 11 Prolonged crying.
Figures and Tables -
Analysis 1.11

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 12 Vomiting.
Figures and Tables -
Analysis 1.12

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 13 Pain/tenderness.
Figures and Tables -
Analysis 1.13

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 14 Redness.
Figures and Tables -
Analysis 1.14

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

Comparison 1 Safety: acellular versus whole‐cell pertussis vaccines, Outcome 15 Swelling/induration.
Figures and Tables -
Analysis 1.15

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 1 Primary series non‐completion due to adverse events.
Figures and Tables -
Analysis 2.1

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 2 Death (all causes).
Figures and Tables -
Analysis 2.2

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 3 Death (infection).
Figures and Tables -
Analysis 2.3

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 4 Encephalopathy.
Figures and Tables -
Analysis 2.4

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 5 Convulsions.
Figures and Tables -
Analysis 2.5

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 6 Hypotonic hyporesponsive episodes.
Figures and Tables -
Analysis 2.6

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 7 Anorexia.
Figures and Tables -
Analysis 2.7

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 8 Drowsiness.
Figures and Tables -
Analysis 2.8

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 9 Fever.
Figures and Tables -
Analysis 2.9

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 10 Irritability/fretfulness.
Figures and Tables -
Analysis 2.10

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 11 Prolonged crying.
Figures and Tables -
Analysis 2.11

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 12 Vomiting.
Figures and Tables -
Analysis 2.12

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 13 Pain/tenderness.
Figures and Tables -
Analysis 2.13

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 14 Swelling/induration.
Figures and Tables -
Analysis 2.14

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

Comparison 2 Safety: acellular vaccines versus placebo/DT, Outcome 15 Redness.
Figures and Tables -
Analysis 2.15

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

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]

Figures and Tables -
Comparison 1. Safety: acellular versus whole‐cell pertussis vaccines
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]

Figures and Tables -
Comparison 2. Safety: acellular vaccines versus placebo/DT