Table 2 Summary proportions of cases with known or unknown baseline serostatus across stratifications

From: Refined efficacy estimates of the Sanofi Pasteur dengue vaccine CYD-TDV using machine learning

 

Known baseline serostatus

Unknown baseline serostatus

p-value

 

Cases

Non-cases

%cases

Cases

Non-cases

%cases

 

Age-group

       

 All ages (2–16 years)

155

4096

3.6

1242

29,527

4.0

0.239

 2–8 years

66

1183

5.3

405

6073

6.3

0.213

 9–11 years

48

1363

3.4

473

11,703

3.9

0.412

 12–16 years

41

1550

2.6

364

11,751

3.0

0.385

Arm

       

CYD-TDV

65

2774

2.3

579

19,943

2.8

0.118

 Placebo

90

1322

6.4

663

9584

6.5

0.936

Country

       

 Brazil

12

288

4.0

107

3137

3.3

0.633

 Colombia

23

890

2.5

250

8555

2.8

0.651

 Honduras

1

294

0.3

112

2379

4.5

0.001

 Indonesia

19

320

5.6

64

1447

4.2

0.339

 Mexico

7

314

2.2

128

3000

4.1

0.126

 Malaysia

6

291

2.0

24

1075

2.2

1

 Philippines

30

564

5.1

265

2611

9.2

0.001

 Puerto Rico

6

145

4.0

18

1145

1.5

0.076

 Thailand (CYD23)

13

287

4.3

122

3580

3.3

0.429

 Thailand (CYD14)

22

314

6.5

68

759

8.2

0.396

 Vietnam

16

389

4.0

84

1839

4.4

0.809

Gender

       

 Female

69

2097

3.2

627

15,078

4.0

0.078

 Male

86

1999

4.1

615

14,449

4.1

0.974

PD3 titres against any serotype

       

 Known

127

3992

3.1

658

19

97.2

<0.001

 Unknown

28

104

21.2

584

29,508

1.9

<0.001

Serotype

       

 DENV1

53

–

–

410

–

–

–

 DENV2

37

–

–

370

–

–

–

 DENV3

30

–

–

217

–

–

–

 DENV4

29

–

–

201

–

–

–

 Unknown

6

–

–

44

–

–

–

Trial

       

 CYD23 (phase-2b)

13

287

4.3

122

3580

3.3

0.429

 CYD14 (phase-3)

93

1878

4.7

505

7731

6.1

0.019

 CYD15 (phase-3)

49

1931

2.5

615

18,216

3.3

0.066

  1. Cases and non-cases occurred during the active surveillance phase (up to 25 months after the first dose) in the phase-2b and phase-3 trials (CYD23, CYD14 and CYD15), stratified by baseline serostatus, age, arm, country of enrolment, gender, PD3 titre availability, serotype of infection (for cases) and trial. In each stratification the percentage of cases were calculated by dividing the number of cases by the total number of cases and non-cases. The p-values were obtained with the Pearson’s chi-squared test using the number of cases and non-cases with known and unknown baseline serostatus in each stratification. Significant (<0.05) p-values are in bold
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