Skip to Main Content
TABLE 2

Summary of Uncommon Adverse Events in Selected Subgroups Evaluated With Historical Comparison Groups Using MaxSPRT and CMaxSPRT

AEType of SPRT AnalysisaSubgroup, Sex, Age Group in yNo. Observed VaccinationsNo. Observed AENo. Comparator Vaccinations, Historical PeriodNo. AEs in the Historical PeriodNo. Expected AEsRRTest StatisticCritical ValuebSignal
Anaphylaxis Maximized Male, 9–17 334 381 — — 0.9 2.7 No 
 CMax Male, 9–17 334 381 1 053 642 — 2.6 No 
Appendicitis Maximized Male, 9–17 78 885 33 — — 25.6 1.3 0.97 3.5 No 
 CMax Male, 9–17 78 885 33 1 053 642 312 — 1.4 1.6 3.8 No 
GBS Maximized Female, 18–26 128 645 — — 0.6 2.6 No 
 CMax Female, 18–26 128 645 431 401 — 2.7 No 
Pancreatitis Maximized Male, 18–26 51 944 — — 2.6 3.1 3.7 2.9 Yes 
 CMax Male, 18–26 51 944 349 966 29 — 1.9 1.1 3.4 No 
Seizures Maximized Female, 9–17 304 384 44 — — 115.2 0.4 3.8 No 
 CMax Female, 9–17 304 384 44 698 263 105 — 1.0 3.7 No 
Stroke Maximized Female, 18–26 128 645 — — 4.9 1.0 2.9 No 
 CMax Female, 18–26 128 645 431 401 11 — 1.5 0.3 2.9 No 
VTE Maximized Female, 18–26 128 645 — — 9.8 0.8 3.1 No 
 CMax Female, 18–26 128 645 431 401 54 — 0.5 3.4 No 
AEType of SPRT AnalysisaSubgroup, Sex, Age Group in yNo. Observed VaccinationsNo. Observed AENo. Comparator Vaccinations, Historical PeriodNo. AEs in the Historical PeriodNo. Expected AEsRRTest StatisticCritical ValuebSignal
Anaphylaxis Maximized Male, 9–17 334 381 — — 0.9 2.7 No 
 CMax Male, 9–17 334 381 1 053 642 — 2.6 No 
Appendicitis Maximized Male, 9–17 78 885 33 — — 25.6 1.3 0.97 3.5 No 
 CMax Male, 9–17 78 885 33 1 053 642 312 — 1.4 1.6 3.8 No 
GBS Maximized Female, 18–26 128 645 — — 0.6 2.6 No 
 CMax Female, 18–26 128 645 431 401 — 2.7 No 
Pancreatitis Maximized Male, 18–26 51 944 — — 2.6 3.1 3.7 2.9 Yes 
 CMax Male, 18–26 51 944 349 966 29 — 1.9 1.1 3.4 No 
Seizures Maximized Female, 9–17 304 384 44 — — 115.2 0.4 3.8 No 
 CMax Female, 9–17 304 384 44 698 263 105 — 1.0 3.7 No 
Stroke Maximized Female, 18–26 128 645 — — 4.9 1.0 2.9 No 
 CMax Female, 18–26 128 645 431 401 11 — 1.5 0.3 2.9 No 
VTE Maximized Female, 18–26 128 645 — — 9.8 0.8 3.1 No 
 CMax Female, 18–26 128 645 431 401 54 — 0.5 3.4 No 

Results were extracted from the final report (week starting October 1, 2017) for all events except for pancreatitis, which comes from the week when it first signaled (week 71). CIDP was not included because there were no events during the study period. AE, adverse event; CMax, conditional maximized; SPRT, sequential probability ratio test; —, not applicable.

a

MaxSPRT: analyses were conducted in combination with the general VSD population historic comparison group (2007–2014). CMaxSPRT: analyses were conducted in combination with the historic VSD population vaccinated with comparator vaccines (2007–2014).

b

Critical values are threshold values of the test statistic above, in which the null hypothesis would be rejected.

Close Modal

or Create an Account

Close Modal
Close Modal