Table 2.
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Serious Adverse Event (SAE) Incidence Among Participants in the Sierra Leone Trial to Introduce a Vaccine Against Ebola, by Vaccination Status

VariableIncidence, SAEs/100 Person-Years (95% CI)Pa
Immediate Vaccinated (n = 4172; 2022 y)Unvaccinated (n = 4398; 1703 y)Crossover Vaccinated (n = 3787; 1832 y)
SAE
 Any2.97 (2.26–3.82)1.94 (1.33–2.72)2.73 (2.03–3.60).046
 During mo 16.72 (4.26–10.08)2.22 (.96–4.36)3.54 (1.77–6.34).004
 During mo 21.17 (.32–2.99)1.39 (.45–3.24)1.94 (.71–4.22).80
 During mo 34.10 (2.24–6.89)1.12 (.31–2.87)1.62 (.53–3.79).012
 During mo 42.06 (.83–4.25)2.34 (1.01–4.62)2.29 (.92–4.71).81
 During mo 51.19 (.32–3.04)2.58 (.95–5.62)3.62 (1.81–6.48).22
 During mo 62.50 (1.08–4.93)3.91 (.47–14.13)3.39 (1.63–6.23).59
SAE-defining criteria
 Death0.40 (.17–.78)0.35 (.13–0.77)0.55 (.26–1.00).83
 Life-threatening0.10 (.01–.36)0.18 (.04–0.51)0.16 (.03–.48).52
 Hospitalization2.57 (1.92–3.37)1.88 (1.29–2.65)2.51 (1.84–3.35).16
 Prolongation of hospitalization0.10 (.01–.36).......12
 Significant disability or incapacity0.05 (.00–.28)0.23 (.06–.60)0.16 (.03–.48).12
 Medical event defined as SAE but did not meet above criteria0.15 (.03–.43).......06
MedDRA system organ class
 Blood and lymphatic system disorders0.15 (.03–.43)0.12 (.01–.42)....80
 Cardiac disorders......0.05 (.00–.30)
 Eye disorders......0.05 (.00–.30)
 Gastrointestinal disorders0.69 (.38–1.16)0.29 (.10–.69)0.55 (.26–1.00).08
 General disorders and administration site conditions0.10 (.01–.36)0.06 (.00–.33)0.11 (.01–.39).66
 Hepatobiliary disorders......0.05 (.00–.30)
 Infections and infestations1.14 (.72–1.71)0.41 (.17–.85)1.04 (.62–1.62).011
 Injury, poisoning, and procedural complications0.15 (.03–.43)0.53 (.24–1.00)0.33 (.12–.71).039
 Metabolism and nutrition disorders0.05 (.00–.28)0.06 (.00–.33)....90
 Neoplasms benign, malignant, and unspecified (including cysts/polyps)0.15 (.03–.43)0.35 (.13–.77)0.05 (.00–.30).21
 Nervous system disorders0.15 (.03–.43)0.06 (.00–.33)0.16 (.03–.48).39
 Pregnancy, puerperium, and perinatal conditions0.05 (.00–.28).......27
 Psychiatric disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Renal and urinary disorders...0.06 (.00–.33)0.05 (.00–.30).21
 Reproductive system and breast disorders0.10 (.01–.36)...0.11 (.01–.39).12
 Respiratory, thoracic, and mediastinal disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Vascular disorders0.15 (.03–.43)...0.05 (.00–.30).06
VariableIncidence, SAEs/100 Person-Years (95% CI)Pa
Immediate Vaccinated (n = 4172; 2022 y)Unvaccinated (n = 4398; 1703 y)Crossover Vaccinated (n = 3787; 1832 y)
SAE
 Any2.97 (2.26–3.82)1.94 (1.33–2.72)2.73 (2.03–3.60).046
 During mo 16.72 (4.26–10.08)2.22 (.96–4.36)3.54 (1.77–6.34).004
 During mo 21.17 (.32–2.99)1.39 (.45–3.24)1.94 (.71–4.22).80
 During mo 34.10 (2.24–6.89)1.12 (.31–2.87)1.62 (.53–3.79).012
 During mo 42.06 (.83–4.25)2.34 (1.01–4.62)2.29 (.92–4.71).81
 During mo 51.19 (.32–3.04)2.58 (.95–5.62)3.62 (1.81–6.48).22
 During mo 62.50 (1.08–4.93)3.91 (.47–14.13)3.39 (1.63–6.23).59
SAE-defining criteria
 Death0.40 (.17–.78)0.35 (.13–0.77)0.55 (.26–1.00).83
 Life-threatening0.10 (.01–.36)0.18 (.04–0.51)0.16 (.03–.48).52
 Hospitalization2.57 (1.92–3.37)1.88 (1.29–2.65)2.51 (1.84–3.35).16
 Prolongation of hospitalization0.10 (.01–.36).......12
 Significant disability or incapacity0.05 (.00–.28)0.23 (.06–.60)0.16 (.03–.48).12
 Medical event defined as SAE but did not meet above criteria0.15 (.03–.43).......06
MedDRA system organ class
 Blood and lymphatic system disorders0.15 (.03–.43)0.12 (.01–.42)....80
 Cardiac disorders......0.05 (.00–.30)
 Eye disorders......0.05 (.00–.30)
 Gastrointestinal disorders0.69 (.38–1.16)0.29 (.10–.69)0.55 (.26–1.00).08
 General disorders and administration site conditions0.10 (.01–.36)0.06 (.00–.33)0.11 (.01–.39).66
 Hepatobiliary disorders......0.05 (.00–.30)
 Infections and infestations1.14 (.72–1.71)0.41 (.17–.85)1.04 (.62–1.62).011
 Injury, poisoning, and procedural complications0.15 (.03–.43)0.53 (.24–1.00)0.33 (.12–.71).039
 Metabolism and nutrition disorders0.05 (.00–.28)0.06 (.00–.33)....90
 Neoplasms benign, malignant, and unspecified (including cysts/polyps)0.15 (.03–.43)0.35 (.13–.77)0.05 (.00–.30).21
 Nervous system disorders0.15 (.03–.43)0.06 (.00–.33)0.16 (.03–.48).39
 Pregnancy, puerperium, and perinatal conditions0.05 (.00–.28).......27
 Psychiatric disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Renal and urinary disorders...0.06 (.00–.33)0.05 (.00–.30).21
 Reproductive system and breast disorders0.10 (.01–.36)...0.11 (.01–.39).12
 Respiratory, thoracic, and mediastinal disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Vascular disorders0.15 (.03–.43)...0.05 (.00–.30).06

Abbreviation: MeDRA, Medical Dictionary for Regulatory Activities, Version 19.0.

aFor comparison of the incidence between participants in the immediate-vaccinated and unvaccinated groups. P values <.05 are given to 3 decimal places.

Table 2.
Open in new tab

Serious Adverse Event (SAE) Incidence Among Participants in the Sierra Leone Trial to Introduce a Vaccine Against Ebola, by Vaccination Status

VariableIncidence, SAEs/100 Person-Years (95% CI)Pa
Immediate Vaccinated (n = 4172; 2022 y)Unvaccinated (n = 4398; 1703 y)Crossover Vaccinated (n = 3787; 1832 y)
SAE
 Any2.97 (2.26–3.82)1.94 (1.33–2.72)2.73 (2.03–3.60).046
 During mo 16.72 (4.26–10.08)2.22 (.96–4.36)3.54 (1.77–6.34).004
 During mo 21.17 (.32–2.99)1.39 (.45–3.24)1.94 (.71–4.22).80
 During mo 34.10 (2.24–6.89)1.12 (.31–2.87)1.62 (.53–3.79).012
 During mo 42.06 (.83–4.25)2.34 (1.01–4.62)2.29 (.92–4.71).81
 During mo 51.19 (.32–3.04)2.58 (.95–5.62)3.62 (1.81–6.48).22
 During mo 62.50 (1.08–4.93)3.91 (.47–14.13)3.39 (1.63–6.23).59
SAE-defining criteria
 Death0.40 (.17–.78)0.35 (.13–0.77)0.55 (.26–1.00).83
 Life-threatening0.10 (.01–.36)0.18 (.04–0.51)0.16 (.03–.48).52
 Hospitalization2.57 (1.92–3.37)1.88 (1.29–2.65)2.51 (1.84–3.35).16
 Prolongation of hospitalization0.10 (.01–.36).......12
 Significant disability or incapacity0.05 (.00–.28)0.23 (.06–.60)0.16 (.03–.48).12
 Medical event defined as SAE but did not meet above criteria0.15 (.03–.43).......06
MedDRA system organ class
 Blood and lymphatic system disorders0.15 (.03–.43)0.12 (.01–.42)....80
 Cardiac disorders......0.05 (.00–.30)
 Eye disorders......0.05 (.00–.30)
 Gastrointestinal disorders0.69 (.38–1.16)0.29 (.10–.69)0.55 (.26–1.00).08
 General disorders and administration site conditions0.10 (.01–.36)0.06 (.00–.33)0.11 (.01–.39).66
 Hepatobiliary disorders......0.05 (.00–.30)
 Infections and infestations1.14 (.72–1.71)0.41 (.17–.85)1.04 (.62–1.62).011
 Injury, poisoning, and procedural complications0.15 (.03–.43)0.53 (.24–1.00)0.33 (.12–.71).039
 Metabolism and nutrition disorders0.05 (.00–.28)0.06 (.00–.33)....90
 Neoplasms benign, malignant, and unspecified (including cysts/polyps)0.15 (.03–.43)0.35 (.13–.77)0.05 (.00–.30).21
 Nervous system disorders0.15 (.03–.43)0.06 (.00–.33)0.16 (.03–.48).39
 Pregnancy, puerperium, and perinatal conditions0.05 (.00–.28).......27
 Psychiatric disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Renal and urinary disorders...0.06 (.00–.33)0.05 (.00–.30).21
 Reproductive system and breast disorders0.10 (.01–.36)...0.11 (.01–.39).12
 Respiratory, thoracic, and mediastinal disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Vascular disorders0.15 (.03–.43)...0.05 (.00–.30).06
VariableIncidence, SAEs/100 Person-Years (95% CI)Pa
Immediate Vaccinated (n = 4172; 2022 y)Unvaccinated (n = 4398; 1703 y)Crossover Vaccinated (n = 3787; 1832 y)
SAE
 Any2.97 (2.26–3.82)1.94 (1.33–2.72)2.73 (2.03–3.60).046
 During mo 16.72 (4.26–10.08)2.22 (.96–4.36)3.54 (1.77–6.34).004
 During mo 21.17 (.32–2.99)1.39 (.45–3.24)1.94 (.71–4.22).80
 During mo 34.10 (2.24–6.89)1.12 (.31–2.87)1.62 (.53–3.79).012
 During mo 42.06 (.83–4.25)2.34 (1.01–4.62)2.29 (.92–4.71).81
 During mo 51.19 (.32–3.04)2.58 (.95–5.62)3.62 (1.81–6.48).22
 During mo 62.50 (1.08–4.93)3.91 (.47–14.13)3.39 (1.63–6.23).59
SAE-defining criteria
 Death0.40 (.17–.78)0.35 (.13–0.77)0.55 (.26–1.00).83
 Life-threatening0.10 (.01–.36)0.18 (.04–0.51)0.16 (.03–.48).52
 Hospitalization2.57 (1.92–3.37)1.88 (1.29–2.65)2.51 (1.84–3.35).16
 Prolongation of hospitalization0.10 (.01–.36).......12
 Significant disability or incapacity0.05 (.00–.28)0.23 (.06–.60)0.16 (.03–.48).12
 Medical event defined as SAE but did not meet above criteria0.15 (.03–.43).......06
MedDRA system organ class
 Blood and lymphatic system disorders0.15 (.03–.43)0.12 (.01–.42)....80
 Cardiac disorders......0.05 (.00–.30)
 Eye disorders......0.05 (.00–.30)
 Gastrointestinal disorders0.69 (.38–1.16)0.29 (.10–.69)0.55 (.26–1.00).08
 General disorders and administration site conditions0.10 (.01–.36)0.06 (.00–.33)0.11 (.01–.39).66
 Hepatobiliary disorders......0.05 (.00–.30)
 Infections and infestations1.14 (.72–1.71)0.41 (.17–.85)1.04 (.62–1.62).011
 Injury, poisoning, and procedural complications0.15 (.03–.43)0.53 (.24–1.00)0.33 (.12–.71).039
 Metabolism and nutrition disorders0.05 (.00–.28)0.06 (.00–.33)....90
 Neoplasms benign, malignant, and unspecified (including cysts/polyps)0.15 (.03–.43)0.35 (.13–.77)0.05 (.00–.30).21
 Nervous system disorders0.15 (.03–.43)0.06 (.00–.33)0.16 (.03–.48).39
 Pregnancy, puerperium, and perinatal conditions0.05 (.00–.28).......27
 Psychiatric disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Renal and urinary disorders...0.06 (.00–.33)0.05 (.00–.30).21
 Reproductive system and breast disorders0.10 (.01–.36)...0.11 (.01–.39).12
 Respiratory, thoracic, and mediastinal disorders0.05 (.00–.28)...0.05 (.00–.30).27
 Vascular disorders0.15 (.03–.43)...0.05 (.00–.30).06

Abbreviation: MeDRA, Medical Dictionary for Regulatory Activities, Version 19.0.

aFor comparison of the incidence between participants in the immediate-vaccinated and unvaccinated groups. P values <.05 are given to 3 decimal places.

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