Vaccine |
Trial |
No. of deaths |
Cause of death |
Vaccine |
Placebo |
Unclear |
Total |
RV1 |
RV1 Anh 2011‐PHL |
1 |
0 |
0 |
1 |
Salmonella gastroenteritis |
RV1 Anh 2011‐VNM |
0 |
0 |
0 |
0 |
— |
RV1 Bernstein 1998‐USA |
0 |
0 |
0 |
0 |
— |
RV1 Bernstein 1999‐USA |
0 |
0 |
1 (1) |
1 |
Pneumococcal sepsis |
RV1 Colgate 2016‐BGD |
1 |
1 |
0 |
2 |
Reasons not reported |
RV1 GSK[021] 2007‐PAN |
0 |
0 |
0 |
0 |
— |
RV1 Tregnaghi 2011‐LA |
10 |
2 |
0 |
12 |
Meningitis bacterial (1 vaccine, 1 placebo), pneumonia (3 vaccine), aortic valve stenosis (1 vaccine), bronchiolitis (1 vaccine), dengue fever (1 vaccine), endocarditis bacterial (1 vaccine), intussusception (1 vaccine), multi‐organ failure (1 placebo), respiratory failure (1 vaccine), sepsis (2 vaccine) |
RV1 GSK[033] 2007‐LA |
3 |
0 |
0 |
3 |
Gastroenteritis (1 vaccine), bronchopneumonia (1 vaccine), aspiration (1 vaccine) |
RV1 GSK[041] 2007‐KOR |
0 |
0 |
0 |
2 |
Not reported |
RV1 GSK[101555] 2008‐PHL |
0 |
0 |
0 |
0 |
— |
RV1 Kawamura 2011‐JPN |
0 |
0 |
0 |
0 |
— |
RV1 Kerdpanich 2010‐THA |
0 |
0 |
0 |
0 |
— |
RV1 Kim 2012‐KOR |
0 |
0 |
0 |
0 |
— |
RV1 Li 2013a‐CHN |
0 |
0 |
0 |
0 |
— |
RV1 Li 2013b‐CHN |
0 |
0 |
0 |
0 |
— |
RV1 Li 2014‐CHN |
6 |
7 |
0 |
13 |
Vaccine (6): Asphyxia, Drowning, Central nervous system infection, Bronchopneumonia, Cortical dysplasia, Intracranial Haemorrhage, Asphyxia, Meningitis, Multi‐organ failure, Hemotophagic histiocytosis, Acute lymphocytic leukemia, Multi‐organ failure
Placebo (7): Diarrhea, Multi‐organ failure, Congenital heart disease, Respiratory failure, brain contusion, subarachnoid hemorrhage, skull fracture, cerebral hematoma, and brain herniation |
RV1 Madhi 2010‐AF |
83 |
43 |
0 |
126 |
Reasons not stated |
RV1 Narang 2009‐IND |
0 |
0 |
0 |
0 |
— |
RV1 NCT00158756‐RUS |
0 |
0 |
0 |
0 |
— |
RV1 Phua 2005‐SGP |
3 |
0 |
0 |
3 |
Leukaemia (1 vaccine); accident‐induced subarachnoid haemorrhage (1 vaccine); cardiorespiratory failure after acute viral pneumonitis (1 vaccine) |
RV1 Phua 2009‐AS |
1 |
3 |
0 |
4 |
Aspiration and metabolic disorder, adenoviral pneumonia, interstitial pneumonia, and sudden infant death syndrome (not stated which group) |
RV1 Rivera 2011‐DOM |
0 |
0 |
0 |
0 |
— |
RV1 Ruiz‐Palac 06‐LA/EU |
56 |
43 |
0 |
99 |
Diarrhoea (4 vaccine, 2 placebo); pneumonia (16 vaccine, 6 placebo); other causes not mentioned |
RV1 Salinas 2005‐LA |
2 |
1 |
0 |
3 |
Generalized visceral congestion (1 placebo); sepsis (1 vaccine); automobile accident (1 vaccine) |
RV1 Steele 2008‐ZAF |
3 |
5 |
0 |
8 |
Bronchopneumonia (1 placebo), pneumonia (2 vaccine, 2 placebo), hepatic steatosis (1 placebo), brain oedema (1 vaccine, 1 placebo) |
RV1 Steele 2010a‐ZAF |
6 |
9 |
0 |
15 |
Bronchopneumonia, sepsis, and gastroenteritis were the most common causes |
RV1 Steele 2010b‐ZAF |
3 |
0 |
0 |
3 |
Bronchopneumonia and gastroenteritis (3 vaccines) |
RV1 Vesikari 2004b‐FIN |
0 |
0 |
0 |
0 |
— |
RV1 Vesikari 2007a‐EU |
0 |
0 |
0 |
0 |
— |
RV1 Vesikari 2011‐FIN |
0 |
0 |
0 |
0 |
— |
RV1 Zaman 2009‐BGD |
1 |
0 |
0 |
1 |
— |
RV5
|
RV5 Armah 2010‐AF |
76 |
82 |
0 |
158 |
Gastroenteritis (20 vaccine, 16 placebo); 11 deaths occurred in identified HIV‐infected participants in Kenya; sudden infant death syndrome (1 placebo); other causes not mentioned |
RV5 Block 2007‐EU/USA |
1 |
0 |
0 |
1 |
Sudden infant death syndrome (1 vaccine) |
RV5 Ciarlet 2009‐EU |
0 |
0 |
0 |
0 |
— |
RV5 Iwata 2013‐JPN |
0 |
0 |
0 |
0 |
— |
RV5 Lawrence 2012‐CHN |
0 |
0 |
0 |
0 |
— |
RV5 Levin 2017‐AF |
1 |
2 |
0 |
3 |
Pneumonia |
RV5 Merck[009] 2005‐USA |
0 |
0 |
0 |
0 |
— |
RV5 Mo 2017‐CHN |
0 |
1 |
0 |
1 |
Reasons not reported |
RV5 Vesikari 2006a‐FIN |
0 |
0 |
0 |
0 |
— |
RV5 Vesikari 2006b‐INT |
24 |
20 |
0 |
44 |
Sudden infant death syndrome (7 vaccine and 7 placebo), other causes not mentioned |
RV5 Zaman 2010‐AS |
3 |
4 |
0 |
7 |
Not all causes reported, most common causes were drowning and sepsis |
Rotavac |
VAC Bhandari 2014‐IND |
30 |
18 |
0 |
48 |
The most common causes of death were infection and infestations followed by general disorders and administration site conditions. Days after vaccination not reported. None were considered to be vaccine‐related |
VAC Chandola 2017‐IND |
5 |
0 |
0 |
5 |
Cause of death: sepsis and aspiration (79 ‐ 141 days after Rotavac vaccination), unexplained sudden death (3 days after Rotavac vaccination). None were considered to be vaccine‐related |